The Experts below are selected from a list of 168 Experts worldwide ranked by ideXlab platform
Jürgen Floege - One of the best experts on this subject based on the ideXlab platform.
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iron kinetics following treatment with Sucroferric Oxyhydroxide or ferric citrate in healthy rats and models of anaemia iron overload or inflammation
Nephrology Dialysis Transplantation, 2020Co-Authors: Jürgen Floege, Anjay Rastogi, Markus Ketteler, Adrian Covic, Sebastian Walpen, Felix Funk, Stuart M. SpragueAbstract:BACKGROUND The iron-based phosphate binders, Sucroferric Oxyhydroxide (SFOH) and ferric citrate (FC), effectively lower serum phosphorus in clinical studies, but gastrointestinal iron absorption from these agents appears to differ. We compared iron uptake and tissue accumulation during treatment with SFOH or FC using experimental rat models. METHODS Iron uptake was evaluated during an 8-h period following oral administration of SFOH, FC, ferrous sulphate (oral iron supplement) or control (methylcellulose vehicle) in rat models of anaemia, iron overload and inflammation. A 13-week study evaluated the effects of SFOH and FC on iron accumulation in different organs. RESULTS In the pharmacokinetic experiments, there was a minimal increase in serum iron with SFOH versus control during the 8-h post-treatment period in the iron overload and inflammation rat models, whereas a moderate increase was observed in the anaemia model. Significantly greater increases (P < 0.05) in serum iron were observed with FC versus SFOH in the rat models of anaemia and inflammation. In the 13-week iron accumulation study, total liver iron content was significantly higher in rats receiving FC versus SFOH (P < 0.01), whereas liver iron content did not differ between rats in the SFOH and control groups. CONCLUSIONS Iron uptake was higher from FC versus SFOH following a single dose in anaemia, iron overload and inflammation rat models and 13 weeks of treatment in normal rats. These observations likely relate to different physicochemical properties of SFOH and FC and suggest distinct mechanisms of iron absorption from these two phosphate binders.
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Phosphate binders in chronic kidney disease: an updated narrative review of recent data
Journal of Nephrology, 2019Co-Authors: Jürgen FloegeAbstract:Chronic kidney disease (CKD) is frequently accompanied by hyperphosphatemia. High serum phosphate usually requires dietary measures, adequate dialysis prescription and/or phosphate binders. For this narrative review a PubMed searched was undertaken to identify new publications on phosphate binders that had been published between January 2015 and July 2019. The present review summarizes this most recent information on dietary measures and their problems in treating hyperphosphatemia in CKD patients, overall effects of phosphate binders on cardiovascular mortality and morbidity, adherence to phosphate binder therapy as well as new data on specific aspects of the various phosphate binders on the market: calcium-containing phosphate binders, polymeric phosphate binders (sevelamer, bixalomer, colestilan), magnesium-containing phosphate binders, lanthanum carbonate, ferric citrate, Sucroferric Oxyhydroxide, and new compounds in development, in particular drugs targeting intestinal phosphate transporters.
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effects of Sucroferric Oxyhydroxide and sevelamer carbonate on chronic kidney disease mineral bone disorder parameters in dialysis patients
Nephrology Dialysis Transplantation, 2019Co-Authors: Markus Ketteler, Viatcheslav Rakov, Anjay Rastogi, Bruce Spinowitz, Adrian Covic, Stuart M. Sprague, Sebastian Walpen, Jürgen FloegeAbstract:BACKGROUND Treatment of hyperphosphataemia is the primary goal of chronic kidney disease-mineral and bone disorder (CKD-MBD) management. This post hoc analysis of a randomized, Phase 3 study evaluated the effects of 1-year treatment with the phosphate binders Sucroferric Oxyhydroxide or sevelamer carbonate ('sevelamer') on CKD-MBD indices among dialysis patients with hyperphosphataemia. METHODS After a 2- to 4-week washout from previous phosphate binders, 1059 patients were randomized 2:1 to Sucroferric Oxyhydroxide 1.0-3.0 g/day (n = 710) or sevelamer 2.4-14.4 g/day (n = 349) for up to 24 weeks. Eligible patients enrolled in a 28-week extension. This post hoc analysis was performed for patients who completed ≥1 year of continuous treatment (n = 549). As the treatment groups showed similar CKD-MBD outcomes, the data were pooled for this analysis. RESULTS Phosphate-binder therapy was associated with significant and sustained 30% reductions in serum phosphorus (P < 0.001). Median intact fibroblast growth factor-23 (FGF-23) also significantly decreased (P < 0.001) by 64% over 1 year. Intact parathyroid hormone decreased significantly after 24 weeks (P < 0.001), but levels returned to near baseline values by Week 52; minimal changes in serum calcium were observed. Of the bone resorption markers evaluated, tartrate-resistant acid phosphatase 5b (TRAP5b) decreased significantly (P < 0.001), whereas CTx increased transiently but returned to baseline levels by Week 52. The bone formation markers bone-specific alkaline phosphatase and osteocalcin both increased over 1 year of treatment. CONCLUSIONS Overall, 1 year of Sucroferric Oxyhydroxide or sevelamer treatment significantly reduced serum FGF-23, which has been associated with clinical benefit in patients with CKD. The trend towards increased bone formation marker levels indicates a beneficial effect on bone metabolism.
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one year efficacy and safety of the iron based phosphate binder Sucroferric Oxyhydroxide in patients on peritoneal dialysis
Nephrology Dialysis Transplantation, 2017Co-Authors: Jürgen Floege, Viatcheslav Rakov, Anjay Rastogi, Bruce Spinowitz, Laura J Lisk, Johannes F.e. Mann, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Background: Sucroferric Oxyhydroxide is a noncalcium, iron-based phosphate binder that demonstrated sustained serum phosphorus control, good tolerability and lower pill burden compared with sevelamer carbonate (sevelamer) in a Phase 3 study conducted in dialysis patients. This subanalysis examines the efficacy and tolerability of Sucroferric Oxyhydroxide and sevelamer in the peritoneal dialysis (PD) patient population. Methods: The initial study (NCT01324128) and its extension (NCT01464190) were multicenter, Phase 3, open-label, randomized (2:1), active-controlled trials comparing Sucroferric Oxyhydroxide (1.0-3.0 g/day) with sevelamer (2.4-14.4 g/day) in dialysis patients over 52 weeks in total. Results: In the overall study, 84/1055 (8.1%) patients received PD and were eligible for efficacy analysis (Sucroferric Oxyhydroxide, n = 56; sevelamer, n = 28). The two groups were broadly comparable to each other and to the overall study population. Serum phosphorus concentrations decreased comparably with both phosphate binders by week 12 (mean change from baseline - 0.6 mmol/L). Over 52 weeks, Sucroferric Oxyhydroxide effectively reduced serum phosphorus concentrations to a similar extent as sevelamer; 62.5% and 64.3% of patients, respectively, were below the Kidney Disease Outcomes Quality Initiative target range (≤1.78 mmol/L). This was achieved with a lower pill burden (3.4 ± 1.3 versus 8.1 ± 3.7 tablets/day) with Sucroferric Oxyhydroxide compared with sevelamer. Treatment adherence rates were 91.2% with Sucroferric Oxyhydroxide and 79.3% with sevelamer. The proportion of patients reporting at least one treatment-emergent adverse event was 86.0% with Sucroferric Oxyhydroxide and 93.1% with sevelamer. The most common adverse events with both treatments were gastrointestinal: diarrhea and discolored feces with Sucroferric Oxyhydroxide and nausea, vomiting and constipation with sevelamer. Conclusions: Sucroferric Oxyhydroxide is noninferior to sevelamer for controlling serum phosphorus in patients undergoing PD, while providing a relatively low pill burden and a high rate of adherence.
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Phosphate binders in chronic kidney disease: a systematic review of recent data
Journal of Nephrology, 2016Co-Authors: Jürgen FloegeAbstract:Hyperphosphatemia is common in chronic kidney disease (CKD) and is treated by dietary measures, dialysis techniques and/or phosphate binders. For the present review PubMed was searched for new publications on phosphate binders appearing between January 2010 and October 2015. This review summarizes the latest information on non-pharmacological measures and their problems in lowering phosphate in CKD patients, effects of phosphate binders on morbidity and mortality, adherence to phosphate binder therapy as well as new information on specific aspects of the various phosphate binders on the market: calcium acetate, calcium carbonate, magnesium-containing phosphate binders, polymeric phosphate binders (sevelamer, bixalomer, colestilan), lanthanum carbonate, ferric citrate, Sucroferric Oxyhydroxide, aluminum-containing phosphate binders, and new compounds in development. The review also briefly covers the emerging field of drugs targeting intestinal phosphate transporters.
Stuart M. Sprague - One of the best experts on this subject based on the ideXlab platform.
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iron kinetics following treatment with Sucroferric Oxyhydroxide or ferric citrate in healthy rats and models of anaemia iron overload or inflammation
Nephrology Dialysis Transplantation, 2020Co-Authors: Jürgen Floege, Anjay Rastogi, Markus Ketteler, Adrian Covic, Sebastian Walpen, Felix Funk, Stuart M. SpragueAbstract:BACKGROUND The iron-based phosphate binders, Sucroferric Oxyhydroxide (SFOH) and ferric citrate (FC), effectively lower serum phosphorus in clinical studies, but gastrointestinal iron absorption from these agents appears to differ. We compared iron uptake and tissue accumulation during treatment with SFOH or FC using experimental rat models. METHODS Iron uptake was evaluated during an 8-h period following oral administration of SFOH, FC, ferrous sulphate (oral iron supplement) or control (methylcellulose vehicle) in rat models of anaemia, iron overload and inflammation. A 13-week study evaluated the effects of SFOH and FC on iron accumulation in different organs. RESULTS In the pharmacokinetic experiments, there was a minimal increase in serum iron with SFOH versus control during the 8-h post-treatment period in the iron overload and inflammation rat models, whereas a moderate increase was observed in the anaemia model. Significantly greater increases (P < 0.05) in serum iron were observed with FC versus SFOH in the rat models of anaemia and inflammation. In the 13-week iron accumulation study, total liver iron content was significantly higher in rats receiving FC versus SFOH (P < 0.01), whereas liver iron content did not differ between rats in the SFOH and control groups. CONCLUSIONS Iron uptake was higher from FC versus SFOH following a single dose in anaemia, iron overload and inflammation rat models and 13 weeks of treatment in normal rats. These observations likely relate to different physicochemical properties of SFOH and FC and suggest distinct mechanisms of iron absorption from these two phosphate binders.
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effects of Sucroferric Oxyhydroxide and sevelamer carbonate on chronic kidney disease mineral bone disorder parameters in dialysis patients
Nephrology Dialysis Transplantation, 2019Co-Authors: Markus Ketteler, Viatcheslav Rakov, Anjay Rastogi, Bruce Spinowitz, Adrian Covic, Stuart M. Sprague, Sebastian Walpen, Jürgen FloegeAbstract:BACKGROUND Treatment of hyperphosphataemia is the primary goal of chronic kidney disease-mineral and bone disorder (CKD-MBD) management. This post hoc analysis of a randomized, Phase 3 study evaluated the effects of 1-year treatment with the phosphate binders Sucroferric Oxyhydroxide or sevelamer carbonate ('sevelamer') on CKD-MBD indices among dialysis patients with hyperphosphataemia. METHODS After a 2- to 4-week washout from previous phosphate binders, 1059 patients were randomized 2:1 to Sucroferric Oxyhydroxide 1.0-3.0 g/day (n = 710) or sevelamer 2.4-14.4 g/day (n = 349) for up to 24 weeks. Eligible patients enrolled in a 28-week extension. This post hoc analysis was performed for patients who completed ≥1 year of continuous treatment (n = 549). As the treatment groups showed similar CKD-MBD outcomes, the data were pooled for this analysis. RESULTS Phosphate-binder therapy was associated with significant and sustained 30% reductions in serum phosphorus (P < 0.001). Median intact fibroblast growth factor-23 (FGF-23) also significantly decreased (P < 0.001) by 64% over 1 year. Intact parathyroid hormone decreased significantly after 24 weeks (P < 0.001), but levels returned to near baseline values by Week 52; minimal changes in serum calcium were observed. Of the bone resorption markers evaluated, tartrate-resistant acid phosphatase 5b (TRAP5b) decreased significantly (P < 0.001), whereas CTx increased transiently but returned to baseline levels by Week 52. The bone formation markers bone-specific alkaline phosphatase and osteocalcin both increased over 1 year of treatment. CONCLUSIONS Overall, 1 year of Sucroferric Oxyhydroxide or sevelamer treatment significantly reduced serum FGF-23, which has been associated with clinical benefit in patients with CKD. The trend towards increased bone formation marker levels indicates a beneficial effect on bone metabolism.
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one year efficacy and safety of the iron based phosphate binder Sucroferric Oxyhydroxide in patients on peritoneal dialysis
Nephrology Dialysis Transplantation, 2017Co-Authors: Jürgen Floege, Viatcheslav Rakov, Anjay Rastogi, Bruce Spinowitz, Laura J Lisk, Johannes F.e. Mann, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Background: Sucroferric Oxyhydroxide is a noncalcium, iron-based phosphate binder that demonstrated sustained serum phosphorus control, good tolerability and lower pill burden compared with sevelamer carbonate (sevelamer) in a Phase 3 study conducted in dialysis patients. This subanalysis examines the efficacy and tolerability of Sucroferric Oxyhydroxide and sevelamer in the peritoneal dialysis (PD) patient population. Methods: The initial study (NCT01324128) and its extension (NCT01464190) were multicenter, Phase 3, open-label, randomized (2:1), active-controlled trials comparing Sucroferric Oxyhydroxide (1.0-3.0 g/day) with sevelamer (2.4-14.4 g/day) in dialysis patients over 52 weeks in total. Results: In the overall study, 84/1055 (8.1%) patients received PD and were eligible for efficacy analysis (Sucroferric Oxyhydroxide, n = 56; sevelamer, n = 28). The two groups were broadly comparable to each other and to the overall study population. Serum phosphorus concentrations decreased comparably with both phosphate binders by week 12 (mean change from baseline - 0.6 mmol/L). Over 52 weeks, Sucroferric Oxyhydroxide effectively reduced serum phosphorus concentrations to a similar extent as sevelamer; 62.5% and 64.3% of patients, respectively, were below the Kidney Disease Outcomes Quality Initiative target range (≤1.78 mmol/L). This was achieved with a lower pill burden (3.4 ± 1.3 versus 8.1 ± 3.7 tablets/day) with Sucroferric Oxyhydroxide compared with sevelamer. Treatment adherence rates were 91.2% with Sucroferric Oxyhydroxide and 79.3% with sevelamer. The proportion of patients reporting at least one treatment-emergent adverse event was 86.0% with Sucroferric Oxyhydroxide and 93.1% with sevelamer. The most common adverse events with both treatments were gastrointestinal: diarrhea and discolored feces with Sucroferric Oxyhydroxide and nausea, vomiting and constipation with sevelamer. Conclusions: Sucroferric Oxyhydroxide is noninferior to sevelamer for controlling serum phosphorus in patients undergoing PD, while providing a relatively low pill burden and a high rate of adherence.
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long term effects of the iron based phosphate binder Sucroferric Oxyhydroxide in dialysis patients
Nephrology Dialysis Transplantation, 2015Co-Authors: Jürgen Floege, Sylvain Gaillard, Anjay Rastogi, Bruce Spinowitz, Edward M F Chong, Laura J Lisk, Johannes F.e. Mann, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Background. Hyperphosphatemia necessitates the use of phosphate binders in most dialysis patients. Long-term efficacy and tolerability of the iron-based phosphate binder, Sucroferric Oxyhydroxide (previously known as PA21), was compared with that of sevelamer carbonate (sevelamer) in an open-label Phase III extension study. Methods. In the initial Phase III study, hemo- or peritoneal dialysis patients with hyperphosphatemia were randomized 2:1 to receive Sucroferric Oxyhydroxide 1.0−3.0 g/day (2−6 tablets/day; n = 710) or sevelamer 2.4−14.4 g/day (3−18 tablets/day; n = 349) for 24 weeks. Eligible patients could enter the 28-week extension study, continuing the same treatment and dose they were receiving at the end of the initial study. Results. Overall, 644 patients were available for efficacy analysis (n = 384 Sucroferric Oxyhydroxide; n= 260 sevelamer). Serum phosphorus concentrations were maintained during the extension study. Mean ± standard deviation (SD) change in serum phosphorus concentrations from extension study baseline to Week 52 end point was 0.02±0.52 mmol/L with Sucroferric Oxyhydroxide and 0.09±0.58 mmol/L with sevelamer. Mean serum phosphorus concentrations remained within Kidney Disease Outcomes Quality Initiative target range (1.13– 1.78 mmol/L) for both treatment groups. Mean (SD) daily tablet number over the 28-week extension study was lower for
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a phase iii study of the efficacy and safety of a novel iron based phosphate binder in dialysis patients
Kidney International, 2014Co-Authors: Jürgen Floege, Sylvain Gaillard, Anjay Rastogi, Edward M F Chong, Laura J Lisk, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Efficacy of PA21 (Sucroferric Oxyhydroxide), a novel calcium-free polynuclear iron(III)-Oxyhydroxide phosphate binder, was compared with that of sevelamer carbonate in an open-label, randomized, active-controlled phase III study. Seven hundred and seven hemo- and peritoneal dialysis patients with hyperphosphatemia received PA21 1.0–3.0g per day and 348 received sevelamer 4.8–14.4g per day for an 8-week dose titration, followed by 4 weeks without dose change, and then 12 weeks maintenance. Serum phosphorus reductions at week 12 were -0.71mmol/l (PA21) and -0.79mmol/l (sevelamer), demonstrating non-inferiority of, on average, three tablets of PA21 vs. eight of sevelamer. Efficacy was maintained to week 24. Non-adherence was 15.1% (PA21) vs. 21.3% (sevelamer). The percentage of patients that reported at least one treatment-emergent adverse event was 83.2% with PA21 and 76.1% with sevelamer. A higher proportion of patients withdrew owing to treatment-emergent adverse events with PA21 (15.7%) vs. sevelamer (6.6%). Mild, transient diarrhea, discolored feces, and hyperphosphatemia were more frequent with PA21; nausea and constipation were more frequent with sevelamer. After 24 weeks, 99 hemodialysis patients on PA21 were re-randomized into a 3-week superiority analysis of PA21 maintenance dose in 50 patients vs. low dose (250mg per day (ineffective control)) in 49 patients. The PA21 maintenance dose was superior to the low dose in maintaining serum phosphorus control. Thus, PA21 was effective in lowering serum phosphorus in dialysis patients, with similar efficacy to sevelamer carbonate, a lower pill burden, and better adherence.
Markus Ketteler - One of the best experts on this subject based on the ideXlab platform.
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iron kinetics following treatment with Sucroferric Oxyhydroxide or ferric citrate in healthy rats and models of anaemia iron overload or inflammation
Nephrology Dialysis Transplantation, 2020Co-Authors: Jürgen Floege, Anjay Rastogi, Markus Ketteler, Adrian Covic, Sebastian Walpen, Felix Funk, Stuart M. SpragueAbstract:BACKGROUND The iron-based phosphate binders, Sucroferric Oxyhydroxide (SFOH) and ferric citrate (FC), effectively lower serum phosphorus in clinical studies, but gastrointestinal iron absorption from these agents appears to differ. We compared iron uptake and tissue accumulation during treatment with SFOH or FC using experimental rat models. METHODS Iron uptake was evaluated during an 8-h period following oral administration of SFOH, FC, ferrous sulphate (oral iron supplement) or control (methylcellulose vehicle) in rat models of anaemia, iron overload and inflammation. A 13-week study evaluated the effects of SFOH and FC on iron accumulation in different organs. RESULTS In the pharmacokinetic experiments, there was a minimal increase in serum iron with SFOH versus control during the 8-h post-treatment period in the iron overload and inflammation rat models, whereas a moderate increase was observed in the anaemia model. Significantly greater increases (P < 0.05) in serum iron were observed with FC versus SFOH in the rat models of anaemia and inflammation. In the 13-week iron accumulation study, total liver iron content was significantly higher in rats receiving FC versus SFOH (P < 0.01), whereas liver iron content did not differ between rats in the SFOH and control groups. CONCLUSIONS Iron uptake was higher from FC versus SFOH following a single dose in anaemia, iron overload and inflammation rat models and 13 weeks of treatment in normal rats. These observations likely relate to different physicochemical properties of SFOH and FC and suggest distinct mechanisms of iron absorption from these two phosphate binders.
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effects of Sucroferric Oxyhydroxide and sevelamer carbonate on chronic kidney disease mineral bone disorder parameters in dialysis patients
Nephrology Dialysis Transplantation, 2019Co-Authors: Markus Ketteler, Viatcheslav Rakov, Anjay Rastogi, Bruce Spinowitz, Adrian Covic, Stuart M. Sprague, Sebastian Walpen, Jürgen FloegeAbstract:BACKGROUND Treatment of hyperphosphataemia is the primary goal of chronic kidney disease-mineral and bone disorder (CKD-MBD) management. This post hoc analysis of a randomized, Phase 3 study evaluated the effects of 1-year treatment with the phosphate binders Sucroferric Oxyhydroxide or sevelamer carbonate ('sevelamer') on CKD-MBD indices among dialysis patients with hyperphosphataemia. METHODS After a 2- to 4-week washout from previous phosphate binders, 1059 patients were randomized 2:1 to Sucroferric Oxyhydroxide 1.0-3.0 g/day (n = 710) or sevelamer 2.4-14.4 g/day (n = 349) for up to 24 weeks. Eligible patients enrolled in a 28-week extension. This post hoc analysis was performed for patients who completed ≥1 year of continuous treatment (n = 549). As the treatment groups showed similar CKD-MBD outcomes, the data were pooled for this analysis. RESULTS Phosphate-binder therapy was associated with significant and sustained 30% reductions in serum phosphorus (P < 0.001). Median intact fibroblast growth factor-23 (FGF-23) also significantly decreased (P < 0.001) by 64% over 1 year. Intact parathyroid hormone decreased significantly after 24 weeks (P < 0.001), but levels returned to near baseline values by Week 52; minimal changes in serum calcium were observed. Of the bone resorption markers evaluated, tartrate-resistant acid phosphatase 5b (TRAP5b) decreased significantly (P < 0.001), whereas CTx increased transiently but returned to baseline levels by Week 52. The bone formation markers bone-specific alkaline phosphatase and osteocalcin both increased over 1 year of treatment. CONCLUSIONS Overall, 1 year of Sucroferric Oxyhydroxide or sevelamer treatment significantly reduced serum FGF-23, which has been associated with clinical benefit in patients with CKD. The trend towards increased bone formation marker levels indicates a beneficial effect on bone metabolism.
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one year efficacy and safety of the iron based phosphate binder Sucroferric Oxyhydroxide in patients on peritoneal dialysis
Nephrology Dialysis Transplantation, 2017Co-Authors: Jürgen Floege, Viatcheslav Rakov, Anjay Rastogi, Bruce Spinowitz, Laura J Lisk, Johannes F.e. Mann, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Background: Sucroferric Oxyhydroxide is a noncalcium, iron-based phosphate binder that demonstrated sustained serum phosphorus control, good tolerability and lower pill burden compared with sevelamer carbonate (sevelamer) in a Phase 3 study conducted in dialysis patients. This subanalysis examines the efficacy and tolerability of Sucroferric Oxyhydroxide and sevelamer in the peritoneal dialysis (PD) patient population. Methods: The initial study (NCT01324128) and its extension (NCT01464190) were multicenter, Phase 3, open-label, randomized (2:1), active-controlled trials comparing Sucroferric Oxyhydroxide (1.0-3.0 g/day) with sevelamer (2.4-14.4 g/day) in dialysis patients over 52 weeks in total. Results: In the overall study, 84/1055 (8.1%) patients received PD and were eligible for efficacy analysis (Sucroferric Oxyhydroxide, n = 56; sevelamer, n = 28). The two groups were broadly comparable to each other and to the overall study population. Serum phosphorus concentrations decreased comparably with both phosphate binders by week 12 (mean change from baseline - 0.6 mmol/L). Over 52 weeks, Sucroferric Oxyhydroxide effectively reduced serum phosphorus concentrations to a similar extent as sevelamer; 62.5% and 64.3% of patients, respectively, were below the Kidney Disease Outcomes Quality Initiative target range (≤1.78 mmol/L). This was achieved with a lower pill burden (3.4 ± 1.3 versus 8.1 ± 3.7 tablets/day) with Sucroferric Oxyhydroxide compared with sevelamer. Treatment adherence rates were 91.2% with Sucroferric Oxyhydroxide and 79.3% with sevelamer. The proportion of patients reporting at least one treatment-emergent adverse event was 86.0% with Sucroferric Oxyhydroxide and 93.1% with sevelamer. The most common adverse events with both treatments were gastrointestinal: diarrhea and discolored feces with Sucroferric Oxyhydroxide and nausea, vomiting and constipation with sevelamer. Conclusions: Sucroferric Oxyhydroxide is noninferior to sevelamer for controlling serum phosphorus in patients undergoing PD, while providing a relatively low pill burden and a high rate of adherence.
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long term effects of the iron based phosphate binder Sucroferric Oxyhydroxide in dialysis patients
Nephrology Dialysis Transplantation, 2015Co-Authors: Jürgen Floege, Sylvain Gaillard, Anjay Rastogi, Bruce Spinowitz, Edward M F Chong, Laura J Lisk, Johannes F.e. Mann, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Background. Hyperphosphatemia necessitates the use of phosphate binders in most dialysis patients. Long-term efficacy and tolerability of the iron-based phosphate binder, Sucroferric Oxyhydroxide (previously known as PA21), was compared with that of sevelamer carbonate (sevelamer) in an open-label Phase III extension study. Methods. In the initial Phase III study, hemo- or peritoneal dialysis patients with hyperphosphatemia were randomized 2:1 to receive Sucroferric Oxyhydroxide 1.0−3.0 g/day (2−6 tablets/day; n = 710) or sevelamer 2.4−14.4 g/day (3−18 tablets/day; n = 349) for 24 weeks. Eligible patients could enter the 28-week extension study, continuing the same treatment and dose they were receiving at the end of the initial study. Results. Overall, 644 patients were available for efficacy analysis (n = 384 Sucroferric Oxyhydroxide; n= 260 sevelamer). Serum phosphorus concentrations were maintained during the extension study. Mean ± standard deviation (SD) change in serum phosphorus concentrations from extension study baseline to Week 52 end point was 0.02±0.52 mmol/L with Sucroferric Oxyhydroxide and 0.09±0.58 mmol/L with sevelamer. Mean serum phosphorus concentrations remained within Kidney Disease Outcomes Quality Initiative target range (1.13– 1.78 mmol/L) for both treatment groups. Mean (SD) daily tablet number over the 28-week extension study was lower for
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a phase iii study of the efficacy and safety of a novel iron based phosphate binder in dialysis patients
Kidney International, 2014Co-Authors: Jürgen Floege, Sylvain Gaillard, Anjay Rastogi, Edward M F Chong, Laura J Lisk, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Efficacy of PA21 (Sucroferric Oxyhydroxide), a novel calcium-free polynuclear iron(III)-Oxyhydroxide phosphate binder, was compared with that of sevelamer carbonate in an open-label, randomized, active-controlled phase III study. Seven hundred and seven hemo- and peritoneal dialysis patients with hyperphosphatemia received PA21 1.0–3.0g per day and 348 received sevelamer 4.8–14.4g per day for an 8-week dose titration, followed by 4 weeks without dose change, and then 12 weeks maintenance. Serum phosphorus reductions at week 12 were -0.71mmol/l (PA21) and -0.79mmol/l (sevelamer), demonstrating non-inferiority of, on average, three tablets of PA21 vs. eight of sevelamer. Efficacy was maintained to week 24. Non-adherence was 15.1% (PA21) vs. 21.3% (sevelamer). The percentage of patients that reported at least one treatment-emergent adverse event was 83.2% with PA21 and 76.1% with sevelamer. A higher proportion of patients withdrew owing to treatment-emergent adverse events with PA21 (15.7%) vs. sevelamer (6.6%). Mild, transient diarrhea, discolored feces, and hyperphosphatemia were more frequent with PA21; nausea and constipation were more frequent with sevelamer. After 24 weeks, 99 hemodialysis patients on PA21 were re-randomized into a 3-week superiority analysis of PA21 maintenance dose in 50 patients vs. low dose (250mg per day (ineffective control)) in 49 patients. The PA21 maintenance dose was superior to the low dose in maintaining serum phosphorus control. Thus, PA21 was effective in lowering serum phosphorus in dialysis patients, with similar efficacy to sevelamer carbonate, a lower pill burden, and better adherence.
Adrian Covic - One of the best experts on this subject based on the ideXlab platform.
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iron kinetics following treatment with Sucroferric Oxyhydroxide or ferric citrate in healthy rats and models of anaemia iron overload or inflammation
Nephrology Dialysis Transplantation, 2020Co-Authors: Jürgen Floege, Anjay Rastogi, Markus Ketteler, Adrian Covic, Sebastian Walpen, Felix Funk, Stuart M. SpragueAbstract:BACKGROUND The iron-based phosphate binders, Sucroferric Oxyhydroxide (SFOH) and ferric citrate (FC), effectively lower serum phosphorus in clinical studies, but gastrointestinal iron absorption from these agents appears to differ. We compared iron uptake and tissue accumulation during treatment with SFOH or FC using experimental rat models. METHODS Iron uptake was evaluated during an 8-h period following oral administration of SFOH, FC, ferrous sulphate (oral iron supplement) or control (methylcellulose vehicle) in rat models of anaemia, iron overload and inflammation. A 13-week study evaluated the effects of SFOH and FC on iron accumulation in different organs. RESULTS In the pharmacokinetic experiments, there was a minimal increase in serum iron with SFOH versus control during the 8-h post-treatment period in the iron overload and inflammation rat models, whereas a moderate increase was observed in the anaemia model. Significantly greater increases (P < 0.05) in serum iron were observed with FC versus SFOH in the rat models of anaemia and inflammation. In the 13-week iron accumulation study, total liver iron content was significantly higher in rats receiving FC versus SFOH (P < 0.01), whereas liver iron content did not differ between rats in the SFOH and control groups. CONCLUSIONS Iron uptake was higher from FC versus SFOH following a single dose in anaemia, iron overload and inflammation rat models and 13 weeks of treatment in normal rats. These observations likely relate to different physicochemical properties of SFOH and FC and suggest distinct mechanisms of iron absorption from these two phosphate binders.
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effects of Sucroferric Oxyhydroxide and sevelamer carbonate on chronic kidney disease mineral bone disorder parameters in dialysis patients
Nephrology Dialysis Transplantation, 2019Co-Authors: Markus Ketteler, Viatcheslav Rakov, Anjay Rastogi, Bruce Spinowitz, Adrian Covic, Stuart M. Sprague, Sebastian Walpen, Jürgen FloegeAbstract:BACKGROUND Treatment of hyperphosphataemia is the primary goal of chronic kidney disease-mineral and bone disorder (CKD-MBD) management. This post hoc analysis of a randomized, Phase 3 study evaluated the effects of 1-year treatment with the phosphate binders Sucroferric Oxyhydroxide or sevelamer carbonate ('sevelamer') on CKD-MBD indices among dialysis patients with hyperphosphataemia. METHODS After a 2- to 4-week washout from previous phosphate binders, 1059 patients were randomized 2:1 to Sucroferric Oxyhydroxide 1.0-3.0 g/day (n = 710) or sevelamer 2.4-14.4 g/day (n = 349) for up to 24 weeks. Eligible patients enrolled in a 28-week extension. This post hoc analysis was performed for patients who completed ≥1 year of continuous treatment (n = 549). As the treatment groups showed similar CKD-MBD outcomes, the data were pooled for this analysis. RESULTS Phosphate-binder therapy was associated with significant and sustained 30% reductions in serum phosphorus (P < 0.001). Median intact fibroblast growth factor-23 (FGF-23) also significantly decreased (P < 0.001) by 64% over 1 year. Intact parathyroid hormone decreased significantly after 24 weeks (P < 0.001), but levels returned to near baseline values by Week 52; minimal changes in serum calcium were observed. Of the bone resorption markers evaluated, tartrate-resistant acid phosphatase 5b (TRAP5b) decreased significantly (P < 0.001), whereas CTx increased transiently but returned to baseline levels by Week 52. The bone formation markers bone-specific alkaline phosphatase and osteocalcin both increased over 1 year of treatment. CONCLUSIONS Overall, 1 year of Sucroferric Oxyhydroxide or sevelamer treatment significantly reduced serum FGF-23, which has been associated with clinical benefit in patients with CKD. The trend towards increased bone formation marker levels indicates a beneficial effect on bone metabolism.
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one year efficacy and safety of the iron based phosphate binder Sucroferric Oxyhydroxide in patients on peritoneal dialysis
Nephrology Dialysis Transplantation, 2017Co-Authors: Jürgen Floege, Viatcheslav Rakov, Anjay Rastogi, Bruce Spinowitz, Laura J Lisk, Johannes F.e. Mann, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Background: Sucroferric Oxyhydroxide is a noncalcium, iron-based phosphate binder that demonstrated sustained serum phosphorus control, good tolerability and lower pill burden compared with sevelamer carbonate (sevelamer) in a Phase 3 study conducted in dialysis patients. This subanalysis examines the efficacy and tolerability of Sucroferric Oxyhydroxide and sevelamer in the peritoneal dialysis (PD) patient population. Methods: The initial study (NCT01324128) and its extension (NCT01464190) were multicenter, Phase 3, open-label, randomized (2:1), active-controlled trials comparing Sucroferric Oxyhydroxide (1.0-3.0 g/day) with sevelamer (2.4-14.4 g/day) in dialysis patients over 52 weeks in total. Results: In the overall study, 84/1055 (8.1%) patients received PD and were eligible for efficacy analysis (Sucroferric Oxyhydroxide, n = 56; sevelamer, n = 28). The two groups were broadly comparable to each other and to the overall study population. Serum phosphorus concentrations decreased comparably with both phosphate binders by week 12 (mean change from baseline - 0.6 mmol/L). Over 52 weeks, Sucroferric Oxyhydroxide effectively reduced serum phosphorus concentrations to a similar extent as sevelamer; 62.5% and 64.3% of patients, respectively, were below the Kidney Disease Outcomes Quality Initiative target range (≤1.78 mmol/L). This was achieved with a lower pill burden (3.4 ± 1.3 versus 8.1 ± 3.7 tablets/day) with Sucroferric Oxyhydroxide compared with sevelamer. Treatment adherence rates were 91.2% with Sucroferric Oxyhydroxide and 79.3% with sevelamer. The proportion of patients reporting at least one treatment-emergent adverse event was 86.0% with Sucroferric Oxyhydroxide and 93.1% with sevelamer. The most common adverse events with both treatments were gastrointestinal: diarrhea and discolored feces with Sucroferric Oxyhydroxide and nausea, vomiting and constipation with sevelamer. Conclusions: Sucroferric Oxyhydroxide is noninferior to sevelamer for controlling serum phosphorus in patients undergoing PD, while providing a relatively low pill burden and a high rate of adherence.
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long term effects of the iron based phosphate binder Sucroferric Oxyhydroxide in dialysis patients
Nephrology Dialysis Transplantation, 2015Co-Authors: Jürgen Floege, Sylvain Gaillard, Anjay Rastogi, Bruce Spinowitz, Edward M F Chong, Laura J Lisk, Johannes F.e. Mann, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Background. Hyperphosphatemia necessitates the use of phosphate binders in most dialysis patients. Long-term efficacy and tolerability of the iron-based phosphate binder, Sucroferric Oxyhydroxide (previously known as PA21), was compared with that of sevelamer carbonate (sevelamer) in an open-label Phase III extension study. Methods. In the initial Phase III study, hemo- or peritoneal dialysis patients with hyperphosphatemia were randomized 2:1 to receive Sucroferric Oxyhydroxide 1.0−3.0 g/day (2−6 tablets/day; n = 710) or sevelamer 2.4−14.4 g/day (3−18 tablets/day; n = 349) for 24 weeks. Eligible patients could enter the 28-week extension study, continuing the same treatment and dose they were receiving at the end of the initial study. Results. Overall, 644 patients were available for efficacy analysis (n = 384 Sucroferric Oxyhydroxide; n= 260 sevelamer). Serum phosphorus concentrations were maintained during the extension study. Mean ± standard deviation (SD) change in serum phosphorus concentrations from extension study baseline to Week 52 end point was 0.02±0.52 mmol/L with Sucroferric Oxyhydroxide and 0.09±0.58 mmol/L with sevelamer. Mean serum phosphorus concentrations remained within Kidney Disease Outcomes Quality Initiative target range (1.13– 1.78 mmol/L) for both treatment groups. Mean (SD) daily tablet number over the 28-week extension study was lower for
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a phase iii study of the efficacy and safety of a novel iron based phosphate binder in dialysis patients
Kidney International, 2014Co-Authors: Jürgen Floege, Sylvain Gaillard, Anjay Rastogi, Edward M F Chong, Laura J Lisk, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Efficacy of PA21 (Sucroferric Oxyhydroxide), a novel calcium-free polynuclear iron(III)-Oxyhydroxide phosphate binder, was compared with that of sevelamer carbonate in an open-label, randomized, active-controlled phase III study. Seven hundred and seven hemo- and peritoneal dialysis patients with hyperphosphatemia received PA21 1.0–3.0g per day and 348 received sevelamer 4.8–14.4g per day for an 8-week dose titration, followed by 4 weeks without dose change, and then 12 weeks maintenance. Serum phosphorus reductions at week 12 were -0.71mmol/l (PA21) and -0.79mmol/l (sevelamer), demonstrating non-inferiority of, on average, three tablets of PA21 vs. eight of sevelamer. Efficacy was maintained to week 24. Non-adherence was 15.1% (PA21) vs. 21.3% (sevelamer). The percentage of patients that reported at least one treatment-emergent adverse event was 83.2% with PA21 and 76.1% with sevelamer. A higher proportion of patients withdrew owing to treatment-emergent adverse events with PA21 (15.7%) vs. sevelamer (6.6%). Mild, transient diarrhea, discolored feces, and hyperphosphatemia were more frequent with PA21; nausea and constipation were more frequent with sevelamer. After 24 weeks, 99 hemodialysis patients on PA21 were re-randomized into a 3-week superiority analysis of PA21 maintenance dose in 50 patients vs. low dose (250mg per day (ineffective control)) in 49 patients. The PA21 maintenance dose was superior to the low dose in maintaining serum phosphorus control. Thus, PA21 was effective in lowering serum phosphorus in dialysis patients, with similar efficacy to sevelamer carbonate, a lower pill burden, and better adherence.
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iron kinetics following treatment with Sucroferric Oxyhydroxide or ferric citrate in healthy rats and models of anaemia iron overload or inflammation
Nephrology Dialysis Transplantation, 2020Co-Authors: Jürgen Floege, Anjay Rastogi, Markus Ketteler, Adrian Covic, Sebastian Walpen, Felix Funk, Stuart M. SpragueAbstract:BACKGROUND The iron-based phosphate binders, Sucroferric Oxyhydroxide (SFOH) and ferric citrate (FC), effectively lower serum phosphorus in clinical studies, but gastrointestinal iron absorption from these agents appears to differ. We compared iron uptake and tissue accumulation during treatment with SFOH or FC using experimental rat models. METHODS Iron uptake was evaluated during an 8-h period following oral administration of SFOH, FC, ferrous sulphate (oral iron supplement) or control (methylcellulose vehicle) in rat models of anaemia, iron overload and inflammation. A 13-week study evaluated the effects of SFOH and FC on iron accumulation in different organs. RESULTS In the pharmacokinetic experiments, there was a minimal increase in serum iron with SFOH versus control during the 8-h post-treatment period in the iron overload and inflammation rat models, whereas a moderate increase was observed in the anaemia model. Significantly greater increases (P < 0.05) in serum iron were observed with FC versus SFOH in the rat models of anaemia and inflammation. In the 13-week iron accumulation study, total liver iron content was significantly higher in rats receiving FC versus SFOH (P < 0.01), whereas liver iron content did not differ between rats in the SFOH and control groups. CONCLUSIONS Iron uptake was higher from FC versus SFOH following a single dose in anaemia, iron overload and inflammation rat models and 13 weeks of treatment in normal rats. These observations likely relate to different physicochemical properties of SFOH and FC and suggest distinct mechanisms of iron absorption from these two phosphate binders.
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effects of Sucroferric Oxyhydroxide and sevelamer carbonate on chronic kidney disease mineral bone disorder parameters in dialysis patients
Nephrology Dialysis Transplantation, 2019Co-Authors: Markus Ketteler, Viatcheslav Rakov, Anjay Rastogi, Bruce Spinowitz, Adrian Covic, Stuart M. Sprague, Sebastian Walpen, Jürgen FloegeAbstract:BACKGROUND Treatment of hyperphosphataemia is the primary goal of chronic kidney disease-mineral and bone disorder (CKD-MBD) management. This post hoc analysis of a randomized, Phase 3 study evaluated the effects of 1-year treatment with the phosphate binders Sucroferric Oxyhydroxide or sevelamer carbonate ('sevelamer') on CKD-MBD indices among dialysis patients with hyperphosphataemia. METHODS After a 2- to 4-week washout from previous phosphate binders, 1059 patients were randomized 2:1 to Sucroferric Oxyhydroxide 1.0-3.0 g/day (n = 710) or sevelamer 2.4-14.4 g/day (n = 349) for up to 24 weeks. Eligible patients enrolled in a 28-week extension. This post hoc analysis was performed for patients who completed ≥1 year of continuous treatment (n = 549). As the treatment groups showed similar CKD-MBD outcomes, the data were pooled for this analysis. RESULTS Phosphate-binder therapy was associated with significant and sustained 30% reductions in serum phosphorus (P < 0.001). Median intact fibroblast growth factor-23 (FGF-23) also significantly decreased (P < 0.001) by 64% over 1 year. Intact parathyroid hormone decreased significantly after 24 weeks (P < 0.001), but levels returned to near baseline values by Week 52; minimal changes in serum calcium were observed. Of the bone resorption markers evaluated, tartrate-resistant acid phosphatase 5b (TRAP5b) decreased significantly (P < 0.001), whereas CTx increased transiently but returned to baseline levels by Week 52. The bone formation markers bone-specific alkaline phosphatase and osteocalcin both increased over 1 year of treatment. CONCLUSIONS Overall, 1 year of Sucroferric Oxyhydroxide or sevelamer treatment significantly reduced serum FGF-23, which has been associated with clinical benefit in patients with CKD. The trend towards increased bone formation marker levels indicates a beneficial effect on bone metabolism.
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one year efficacy and safety of the iron based phosphate binder Sucroferric Oxyhydroxide in patients on peritoneal dialysis
Nephrology Dialysis Transplantation, 2017Co-Authors: Jürgen Floege, Viatcheslav Rakov, Anjay Rastogi, Bruce Spinowitz, Laura J Lisk, Johannes F.e. Mann, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Background: Sucroferric Oxyhydroxide is a noncalcium, iron-based phosphate binder that demonstrated sustained serum phosphorus control, good tolerability and lower pill burden compared with sevelamer carbonate (sevelamer) in a Phase 3 study conducted in dialysis patients. This subanalysis examines the efficacy and tolerability of Sucroferric Oxyhydroxide and sevelamer in the peritoneal dialysis (PD) patient population. Methods: The initial study (NCT01324128) and its extension (NCT01464190) were multicenter, Phase 3, open-label, randomized (2:1), active-controlled trials comparing Sucroferric Oxyhydroxide (1.0-3.0 g/day) with sevelamer (2.4-14.4 g/day) in dialysis patients over 52 weeks in total. Results: In the overall study, 84/1055 (8.1%) patients received PD and were eligible for efficacy analysis (Sucroferric Oxyhydroxide, n = 56; sevelamer, n = 28). The two groups were broadly comparable to each other and to the overall study population. Serum phosphorus concentrations decreased comparably with both phosphate binders by week 12 (mean change from baseline - 0.6 mmol/L). Over 52 weeks, Sucroferric Oxyhydroxide effectively reduced serum phosphorus concentrations to a similar extent as sevelamer; 62.5% and 64.3% of patients, respectively, were below the Kidney Disease Outcomes Quality Initiative target range (≤1.78 mmol/L). This was achieved with a lower pill burden (3.4 ± 1.3 versus 8.1 ± 3.7 tablets/day) with Sucroferric Oxyhydroxide compared with sevelamer. Treatment adherence rates were 91.2% with Sucroferric Oxyhydroxide and 79.3% with sevelamer. The proportion of patients reporting at least one treatment-emergent adverse event was 86.0% with Sucroferric Oxyhydroxide and 93.1% with sevelamer. The most common adverse events with both treatments were gastrointestinal: diarrhea and discolored feces with Sucroferric Oxyhydroxide and nausea, vomiting and constipation with sevelamer. Conclusions: Sucroferric Oxyhydroxide is noninferior to sevelamer for controlling serum phosphorus in patients undergoing PD, while providing a relatively low pill burden and a high rate of adherence.
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long term effects of the iron based phosphate binder Sucroferric Oxyhydroxide in dialysis patients
Nephrology Dialysis Transplantation, 2015Co-Authors: Jürgen Floege, Sylvain Gaillard, Anjay Rastogi, Bruce Spinowitz, Edward M F Chong, Laura J Lisk, Johannes F.e. Mann, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Background. Hyperphosphatemia necessitates the use of phosphate binders in most dialysis patients. Long-term efficacy and tolerability of the iron-based phosphate binder, Sucroferric Oxyhydroxide (previously known as PA21), was compared with that of sevelamer carbonate (sevelamer) in an open-label Phase III extension study. Methods. In the initial Phase III study, hemo- or peritoneal dialysis patients with hyperphosphatemia were randomized 2:1 to receive Sucroferric Oxyhydroxide 1.0−3.0 g/day (2−6 tablets/day; n = 710) or sevelamer 2.4−14.4 g/day (3−18 tablets/day; n = 349) for 24 weeks. Eligible patients could enter the 28-week extension study, continuing the same treatment and dose they were receiving at the end of the initial study. Results. Overall, 644 patients were available for efficacy analysis (n = 384 Sucroferric Oxyhydroxide; n= 260 sevelamer). Serum phosphorus concentrations were maintained during the extension study. Mean ± standard deviation (SD) change in serum phosphorus concentrations from extension study baseline to Week 52 end point was 0.02±0.52 mmol/L with Sucroferric Oxyhydroxide and 0.09±0.58 mmol/L with sevelamer. Mean serum phosphorus concentrations remained within Kidney Disease Outcomes Quality Initiative target range (1.13– 1.78 mmol/L) for both treatment groups. Mean (SD) daily tablet number over the 28-week extension study was lower for
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a phase iii study of the efficacy and safety of a novel iron based phosphate binder in dialysis patients
Kidney International, 2014Co-Authors: Jürgen Floege, Sylvain Gaillard, Anjay Rastogi, Edward M F Chong, Laura J Lisk, Markus Ketteler, Adrian Covic, Stuart M. SpragueAbstract:Efficacy of PA21 (Sucroferric Oxyhydroxide), a novel calcium-free polynuclear iron(III)-Oxyhydroxide phosphate binder, was compared with that of sevelamer carbonate in an open-label, randomized, active-controlled phase III study. Seven hundred and seven hemo- and peritoneal dialysis patients with hyperphosphatemia received PA21 1.0–3.0g per day and 348 received sevelamer 4.8–14.4g per day for an 8-week dose titration, followed by 4 weeks without dose change, and then 12 weeks maintenance. Serum phosphorus reductions at week 12 were -0.71mmol/l (PA21) and -0.79mmol/l (sevelamer), demonstrating non-inferiority of, on average, three tablets of PA21 vs. eight of sevelamer. Efficacy was maintained to week 24. Non-adherence was 15.1% (PA21) vs. 21.3% (sevelamer). The percentage of patients that reported at least one treatment-emergent adverse event was 83.2% with PA21 and 76.1% with sevelamer. A higher proportion of patients withdrew owing to treatment-emergent adverse events with PA21 (15.7%) vs. sevelamer (6.6%). Mild, transient diarrhea, discolored feces, and hyperphosphatemia were more frequent with PA21; nausea and constipation were more frequent with sevelamer. After 24 weeks, 99 hemodialysis patients on PA21 were re-randomized into a 3-week superiority analysis of PA21 maintenance dose in 50 patients vs. low dose (250mg per day (ineffective control)) in 49 patients. The PA21 maintenance dose was superior to the low dose in maintaining serum phosphorus control. Thus, PA21 was effective in lowering serum phosphorus in dialysis patients, with similar efficacy to sevelamer carbonate, a lower pill burden, and better adherence.
