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Naomi V Dahl - One of the best experts on this subject based on the ideXlab platform.

  • Proteinuria Induced by Parenteral Iron in Chronic Kidney Disease—A Comparative Randomized Controlled
    2016
    Co-Authors: Rajiv Agarwal, David J. Leehey, Scott M. Olsen, Naomi V Dahl
    Abstract:

    Background and objectives Among patients with chronic kidney disease (CKD), differences in proteinuria are seen between intravenous iron preparations after a single dose exposure. This study examined differ-ences in proteinuria between two intravenous iron preparations after multiple doses. Design, setting, participants, & measurements Patients with iron-deficiency anemia and CKD, stratified by angiotensin converting enzyme inhibitor (ACEI)/angiotensin receptor-blocker (ARB) use, were randomized to iron sucrose or Ferric Gluconate. Each patient at 12 centers received 100 mg of study drug weekly for 5 weeks. Urine protein/urine creatinine ratio was measured before each dose and frequently thereafter for 3 hours. Results Postbaseline data were available from 33 patients receiving iron sucrose and 29 patients receiving Ferric Gluconate. Although neither preparation of intravenous iron increased the predose level of protein-uria, the proteinuric response to intravenous iron was dependent on the type of iron and ACEI/ARB use. Without ACEIs/ARBs, Ferric Gluconate tended to cause less proteinuria with repeated iron administration; iron sucrose did not mitigate or aggravate proteinuria. Among patients receiving ACEIs/ARBs, in contrast to Ferric Gluconate, which produced only mild transient proteinuria, iron sucrose produced a consistent and persistent proteinuric response that was on average 78 % greater. Conclusions Although multiple doses of either intravenous iron did not increase basal levels of proteinuria, postdose proteinuria was greater with iron sucrose than with Ferric Gluconate. These data suggest that nephrotoxicity of iron may depend on type of intravenous iron and on ACEI/ARB use. The long-term ef-fects on kidney function need to be further evaluated

  • Proteinuria Induced by Parenteral Iron in Chronic Kidney Disease—A Comparative Randomized Controlled Trial
    Clinical journal of the American Society of Nephrology : CJASN, 2010
    Co-Authors: Rajiv Agarwal, David J. Leehey, Scott M. Olsen, Naomi V Dahl
    Abstract:

    Summary Background and objectives Among patients with chronic kidney disease (CKD), differences in proteinuria are seen between intravenous iron preparations after a single dose exposure. This study examined differences in proteinuria between two intravenous iron preparations after multiple doses. Design, setting, participants, & measurements Patients with iron-deficiency anemia and CKD, stratified by angiotensin converting enzyme inhibitor (ACEI)/angiotensin receptor-blocker (ARB) use, were randomized to iron sucrose or Ferric Gluconate. Each patient at 12 centers received 100 mg of study drug weekly for 5 weeks. Urine protein/urine creatinine ratio was measured before each dose and frequently thereafter for 3 hours. Results Postbaseline data were available from 33 patients receiving iron sucrose and 29 patients receiving Ferric Gluconate. Although neither preparation of intravenous iron increased the predose level of proteinuria, the proteinuric response to intravenous iron was dependent on the type of iron and ACEI/ARB use. Without ACEIs/ARBs, Ferric Gluconate tended to cause less proteinuria with repeated iron administration; iron sucrose did not mitigate or aggravate proteinuria. Among patients receiving ACEIs/ARBs, in contrast to Ferric Gluconate, which produced only mild transient proteinuria, iron sucrose produced a consistent and persistent proteinuric response that was on average 78% greater. Conclusions Although multiple doses of either intravenous iron did not increase basal levels of proteinuria, postdose proteinuria was greater with iron sucrose than with Ferric Gluconate. These data suggest that nephrotoxicity of iron may depend on type of intravenous iron and on ACEI/ARB use. The long-term effects on kidney function need to be further evaluated.

  • Ferric Gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin
    Journal of The American Society of Nephrology, 2008
    Co-Authors: Toros Kapoian, Naomi V Dahl, Neeta B Omara, Ajay K Singh, John Moran, Adel R Rizkala, Robert Geronemus, Robert C Kopelman, Daniel W Coyne
    Abstract:

    The Dialysis Patients Response to IV Iron with Elevated Ferritin (DRIVE) study demonstrated the efficacy of intravenous Ferric Gluconate to improve hemoglobin levels in anemic hemodialysis patients who were receiving adequate epoetin doses and who had ferritin levels between 500 and 1200 ng/ml and transferrin saturation (TSAT) ≤25%. The DRIVE-II study reported here was a 6-wk observational extension designed to investigate how Ferric Gluconate impacted epoetin dosage after DRIVE. During DRIVE-II, treating nephrologists and anemia managers adjusted doses of epoetin and intravenous iron as clinically indicated. By the end of observation, patients in the Ferric Gluconate group required significantly less epoetin than their DRIVE dose (mean change of −7527 ± 18,021 IU/wk, P = 0.003), whereas the epoetin dose essentially did not change for patients in the control group (mean change of 649 ± 19,987 IU/wk, P = 0.809). Mean hemoglobin, TSAT, and serum ferritin levels remained higher in the Ferric Gluconate group than in the control group (P = 0.062, P < 0.001, and P = 0.014, respectively). Over the entire 12-wk study period (DRIVE plus DRIVE-II), the control group experienced significantly more serious adverse events than the Ferric Gluconate group (incidence rate ratio = 1.73, P = 0.041). In conclusion, Ferric Gluconate maintains hemoglobin and allows lower epoetin doses in anemic hemodialysis patients with low TSAT and ferritin levels up to 1200 ng/ml.

  • Ferric Gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin
    Journal of The American Society of Nephrology, 2008
    Co-Authors: Toros Kapoian, Naomi V Dahl, Neeta B Omara, Ajay K Singh, John Moran, Adel R Rizkala, Robert Geronemus, Robert C Kopelman, Daniel W Coyne
    Abstract:

    The Dialysis Patients Response to IV Iron with Elevated Ferritin (DRIVE) study demonstrated the efficacy of intravenous Ferric Gluconate to improve hemoglobin levels in anemic hemodialysis patients who were receiving adequate epoetin doses and who had ferritin levels between 500 and 1200 ng/ml and transferrin saturation (TSAT) ≤25%. The DRIVE-II study reported here was a 6-wk observational extension designed to investigate how Ferric Gluconate impacted epoetin dosage after DRIVE. During DRIVE-II, treating nephrologists and anemia managers adjusted doses of epoetin and intravenous iron as clinically indicated. By the end of observation, patients in the Ferric Gluconate group required significantly less epoetin than their DRIVE dose (mean change of −7527 ± 18,021 IU/wk, P = 0.003), whereas the epoetin dose essentially did not change for patients in the control group (mean change of 649 ± 19,987 IU/wk, P = 0.809). Mean hemoglobin, TSAT, and serum ferritin levels remained higher in the Ferric Gluconate group than in the control group (P = 0.062, P < 0.001, and P = 0.014, respectively). Over the entire 12-wk study period (DRIVE plus DRIVE-II), the control group experienced significantly more serious adverse events than the Ferric Gluconate group (incidence rate ratio = 1.73, P = 0.041). In conclusion, Ferric Gluconate maintains hemoglobin and allows lower epoetin doses in anemic hemodialysis patients with low TSAT and ferritin levels up to 1200 ng/ml.

  • single dosage pharmacokinetics of sodium Ferric Gluconate complex in iron deficient pediatric hemodialysis patients
    Clinical Journal of The American Society of Nephrology, 2007
    Co-Authors: Bradley A Warady, Paul A Seligman, Naomi V Dahl
    Abstract:

    Background and objectives: The clinical use of sodium Ferric Gluconate complex in iron-deficient pediatric patients receiving hemodialysis was recently approved. This study was designed to describe the pharmacokinetic parameters of the medication. Design, setting, participants, & measurements: Iron-deficient pediatric (<15 yr) hemodialysis patients were randomly assigned to two doses (1.5 and 3.0 mg/kg) of sodium Ferric Gluconate complex. Blood samples taken during a 1-h infusion and at multiple intervals during 48 h were analyzed for total iron, transferrin-bound iron, and sodium Ferric Gluconate complex– bound iron. Results: Forty-nine patients (mean age 12.3 2.5 yr) participated in the study. Mean serum iron concentrations rapidly increased in a dosage-dependent manner. A rapid rise in total serum iron was followed by a slower, less prominent rise in transferrin-bound iron. This was qualitatively confirmed by visualization of the transferrin bands from polyacrylamide gel electrophoresis. Single-dose pharmacokinetics of sodium Ferric Gluconate complex–bound iron was described using noncompartmental analytical methods. Mean values for the 1.5 mg/Kg dose were as follows: t1/2 2.0 0.7 h, Cmax 1287 mcg/dl, Tmax 1.1 0.23 h, Cl 0.69 0.50 L/h, Vd 1.6 0.6 L, AUC0-. 9499 4089 mcg hr/dl. Conclusions: The infusion of sodium Ferric Gluconate complex to pediatric patients who receive hemodialysis appears to result in a delayed transfer of iron to transferrin, likely after an initial movement through the reticuloendothelial system. Differences noted between the pediatric and adult pharmacokinetic data may result from the unique aspects of the study populations and the respective study designs.

Jur Strobos - One of the best experts on this subject based on the ideXlab platform.

  • Single-dose pharmacokinetics of sodium Ferric Gluconate complex in iron-deficient subjects.
    Pharmacotherapy, 2004
    Co-Authors: Paul A Seligman, Naomi V Dahl, Jur Strobos, Hui C. Kimko, Rhoda B. Schleicher, Michael A Jones, Murray P. Ducharme
    Abstract:

    Study Objectives. To determine the single-dose pharmacokinetics of intravenous sodium Ferric Gluconate complex in sucrose injection (SFGC) in iron-deficient human volunteers, and to assess iron transport. Design. Open-label, randomized study. Setting. Clinical research facility. Subjects. Fourteen iron-deficient men and women. Interventions. Subjects were randomized to receive a single intravenous dose of either SFGC 62.5 mg administered over 30 minutes or SFGC 125 mg over 60 minutes. Five days later, the same subjects were rerandomized to receive a second intravenous dose of SFGC, either 62.5 mg administered over 4 minutes or 125 mg over 7 minutes. Measurements and Main Results. Blood samples were collected at predefined times before, during, and up to 72 hours after the infusion to determine the single-dose pharmacokinetics of SFGC. Assays were performed for both total iron and transferrin-bound iron, from which drug-bound iron could be calculated. Urine was collected over 24 hours before dosing and for 24 hours after the start of infusion to determine the renal elimination of iron. Clearance of SFGC from serum was rapid and far exceeded rates reported for iron dextran. Pharmacokinetic parameters were unaffected by dose or infusion rate. Serum iron derived from SFGC did not exceed the binding capacity of transferrin. Serum iron from SFGC became rapidly available (< 24 hrs) as transferrin-bound iron, but only after passage through another compartment, presumably the reticuloendothelial system (RES). At least 80% of the administered iron was transported to bone marrow within 24 hours after infusion. Conclusions. Iron derived from SFGC appears to be rapidly transferred to a bioavailable iron compartment as transferrin-bound iron after digestion in the RES. At the doses administered in this study, liberation of potentially toxic, free iron was not detectable.

  • sodium Ferric Gluconate complex in sucrose safer intravenous iron therapy than iron dextrans
    American Journal of Kidney Diseases, 1999
    Co-Authors: Gerald Faich, Jur Strobos
    Abstract:

    Use of recombinant human erythropoietin in patients with end-stage renal disease has highlighted iron deficiency as the major cause of resistant anemia. The current mainstay of intravenous (i.v.) iron replacement therapy, iron dextran, has been shown in prior studies to have a risk of serious life-threatening anaphylaxis of just under 1 per 100 patients exposed. The current study assessed the safety profile of an alternative i.v. iron, sodium Ferric Gluconate complex in sucrose (Ferrlecit), as compared with iron dextrans. Sodium Ferric Gluconate complex in sucrose, a unique chemical preparation, has been in use since 1959, principally in Europe, at a rate of approximately 2.7 million i.v. doses per year (1992 to 1996) in Germany and Italy alone. For iron dextran, usage in the United States was comparable--principally renal hemodialysis--and estimated from market sources at 3.0 million doses per year (1995). From 1976 to 1996, there were 74 allergic adverse events reported for sodium Ferric Gluconate complex in sucrose to the World Health Organization (WHO), German Health Bureau, and the manufacturer (all combined). For the years 1992 to 1996, sodium Ferric Gluconate complex in sucrose had an allergy event reporting rate of 3.3 allergy episodes per million doses per year compared with a similar rate of 8.7 reported allergy events per million doses per year for iron dextran in the United States in 1995. Case fatalities for sodium Ferric Gluconate complex in sucrose and iron dextran within these reports were then compared. For sodium Ferric Gluconate complex in sucrose, there were no reports of deaths over the entire period (1976 to 1996). However, for iron dextrans, there were 31 fatalities among 196 allergy/anaphylaxis cases reported in the United States between 1976 and 1996, yielding a case-fatality rate of 15.8%. These data show that sodium Ferric Gluconate complex in sucrose, when compared with iron dextrans in comparably sized patient usage populations with similar total rates of reporting of allergic events, has a significantly lower reported mortality rate (P < 0.001). Thus, the data justify usage of sodium Ferric Gluconate complex in sucrose as the safer iron replacement therapeutic agent.

  • sodium Ferric Gluconate complex in sucrose safer intravenous iron therapy than iron dextrans
    American Journal of Kidney Diseases, 1999
    Co-Authors: Gerald Faich, Jur Strobos
    Abstract:

    Abstract Use of recombinant human erythropoietin in patients with end-stage renal disease has highlighted iron deficiency as the major cause of resistant anemia. The current mainstay of intravenous (IV) iron replacement therapy, iron dextran, has been shown in prior studies to have a risk of serious life-threatening anaphylaxis of just under 1 per 100 patients exposed. The current study assessed the safety profile of an alternative IV iron, sodium Ferric Gluconate complex in sucrose (Ferrlecit), as compared with iron dextrans. Sodium Ferric Gluconate complex in sucrose, a unique chemical preparation, has been in use since 1959, principally in Europe, at a rate of approximately 2.7 million IV doses per year (1992 to 1996) in Germany and Italy alone. For iron dextran, usage in the United States was comparable—principally renal hemodialysis—and estimated from market sources at 3.0 million doses per year (1995). From 1976 to 1996, there were 74 allergic adverse events reported for sodium Ferric Gluconate complex in sucrose to the World Health Organization (WHO), German Health Bureau, and the manufacturer (all combined). For the years 1992 to 1996, sodium Ferric Gluconate complex in sucrose had an allergy event reporting rate of 3.3 allergy episodes per million doses per year compared with a similar rate of 8.7 reported allergy events per million doses per year for iron dextran in the United States in 1995. Case fatalities for sodium Ferric Gluconate complex in sucrose and iron dextran within these reports were then compared. For sodium Ferric Gluconate complex in sucrose, there were no reports of deaths over the entire period (1976 to 1996). However, for iron dextrans, there were 31 fatalities among 196 allergy/anaphylaxis cases reported in the United States between 1976 and 1996, yielding a case-fatality rate of 15.8%. These data show that sodium Ferric Gluconate complex in sucrose, when compared with iron dextrans in comparably sized patient usage populations with similar total rates of reporting of allergic events, has a significantly lower reported mortality rate ( P

  • sodium Ferric Gluconate complex in sucrose is safe and effective in hemodialysis patients north american clinical trial
    American Journal of Kidney Diseases, 1999
    Co-Authors: Allen R Nissenson, Paul A Seligman, Robert M Lindsay, Suzanne K Swan, Jur Strobos
    Abstract:

    A new intravenous (i.v.) iron compound, sodium Ferric Gluconate complex in sucrose (Ferrlecit, R&D Laboratories, Inc, Marina Del Rey, CA), was administered over 8 consecutive dialysis days in equally divided doses to a total of either 0.5 or 1.0 g in a controlled, open, multicenter, randomized clinical study of anemic, iron-deficient hemodialysis patients receiving recombinant human erythropoietin (rHuEPO). Effectiveness was assessed by increase in hemoglobin and hematocrit and changes of iron parameters. Results were compared with historically matched controls on oral iron. High-dose i.v. treatment with 1.0 g sodium Ferric Gluconate complex in sucrose resulted in significantly greater improvement in hemoglobin, hematocrit, iron saturation, and serum ferritin at all time points, as compared with low-dose i.v. (0.5 g) or oral iron treatment. Despite an initial improvement in mean serum ferritin and transferrin saturation, 500 mg i.v. therapy did not result in a significant improvement in hemoglobin at any time. Eighty-three of 88 patients completed treatment with sodium Ferric Gluconate complex in sucrose: 44 in the high-dose and 39 in the low-dose group. Two patients discontinued for personal reasons. The other three discontinued because of a rash, nausea and rash, and chest pain with pruritus, respectively. In comparison with 25 matched control patients, adverse events could not be linked to drug therapy, nor was there a dose effect. In conclusion, sodium Ferric Gluconate complex in sucrose is safe and effective in the management of iron-deficiency anemia in severely iron-deficient and anemic hemodialysis patients receiving rHuEPO. This study confirms the concepts regarding iron therapy expressed in the National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI) that hemodialysis patients with serum ferritin below 100 ng/mL or transferrin saturations below 18% need supplementation with parenteral iron in excess of 1.0 g to achieve optimal response in hemoglobin and hematocrit levels.

Daniel W Coyne - One of the best experts on this subject based on the ideXlab platform.

  • Ferric Gluconate treatment provides cost savings in patients with high ferritin and low transferrin saturation
    Kidney International, 2008
    Co-Authors: Laura T Pizzi, Daniel W Coyne, Thomas J Bunz, David S Goldfarb, Ajay K Singh
    Abstract:

    A subgroup of hemodialysis patients experience high serum ferritin and low tansferrin saturation for reasons not clearly understood. Here we determined the economic impact of administering sodium Ferric Gluconate complex to patients with serum ferritin levels higher than 500 ng/ml and a transferrin saturation less than 25% based on the Dialysis Patients Response to IV Iron with Elevated Ferritin (DRIVE) study and its extension, DRIVE II. A cost effectiveness model was developed, consistent with the DRIVE studies, using decision analysis with a 12-week time horizon. The primary effectiveness measure was the mean hemoglobin increase in the intent to treat patient groups comparing epoetin with or without sodium Ferric Gluconate complex. Costs were computed using projected 2007 US Medicare reimbursements for the treatments and for serious adverse events, with the effectiveness factored by the increase in hemoglobin. The net savings for sodium Ferric Gluconate complex plus epoetin treatment was $1390 compared to epoetin alone for each g/dl hemoglobin increase over 12 weeks of study. Sensitivity analyses were performed to test the impact of change in the variables (using medians or means and actual 2005 or projected 2007 Medicare reimbursements) and these affirmed the robustness of the model. Our study shows that treatment of patients with high ferritin and low transferrin saturation levels, as defined in DRIVE, with sodium Ferric Gluconate complex and epoetin resulted in significant savings compared to epoetin alone.

  • Ferric Gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin
    Journal of The American Society of Nephrology, 2008
    Co-Authors: Toros Kapoian, Naomi V Dahl, Neeta B Omara, Ajay K Singh, John Moran, Adel R Rizkala, Robert Geronemus, Robert C Kopelman, Daniel W Coyne
    Abstract:

    The Dialysis Patients Response to IV Iron with Elevated Ferritin (DRIVE) study demonstrated the efficacy of intravenous Ferric Gluconate to improve hemoglobin levels in anemic hemodialysis patients who were receiving adequate epoetin doses and who had ferritin levels between 500 and 1200 ng/ml and transferrin saturation (TSAT) ≤25%. The DRIVE-II study reported here was a 6-wk observational extension designed to investigate how Ferric Gluconate impacted epoetin dosage after DRIVE. During DRIVE-II, treating nephrologists and anemia managers adjusted doses of epoetin and intravenous iron as clinically indicated. By the end of observation, patients in the Ferric Gluconate group required significantly less epoetin than their DRIVE dose (mean change of −7527 ± 18,021 IU/wk, P = 0.003), whereas the epoetin dose essentially did not change for patients in the control group (mean change of 649 ± 19,987 IU/wk, P = 0.809). Mean hemoglobin, TSAT, and serum ferritin levels remained higher in the Ferric Gluconate group than in the control group (P = 0.062, P < 0.001, and P = 0.014, respectively). Over the entire 12-wk study period (DRIVE plus DRIVE-II), the control group experienced significantly more serious adverse events than the Ferric Gluconate group (incidence rate ratio = 1.73, P = 0.041). In conclusion, Ferric Gluconate maintains hemoglobin and allows lower epoetin doses in anemic hemodialysis patients with low TSAT and ferritin levels up to 1200 ng/ml.

  • Ferric Gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin
    Journal of The American Society of Nephrology, 2008
    Co-Authors: Toros Kapoian, Naomi V Dahl, Neeta B Omara, Ajay K Singh, John Moran, Adel R Rizkala, Robert Geronemus, Robert C Kopelman, Daniel W Coyne
    Abstract:

    The Dialysis Patients Response to IV Iron with Elevated Ferritin (DRIVE) study demonstrated the efficacy of intravenous Ferric Gluconate to improve hemoglobin levels in anemic hemodialysis patients who were receiving adequate epoetin doses and who had ferritin levels between 500 and 1200 ng/ml and transferrin saturation (TSAT) ≤25%. The DRIVE-II study reported here was a 6-wk observational extension designed to investigate how Ferric Gluconate impacted epoetin dosage after DRIVE. During DRIVE-II, treating nephrologists and anemia managers adjusted doses of epoetin and intravenous iron as clinically indicated. By the end of observation, patients in the Ferric Gluconate group required significantly less epoetin than their DRIVE dose (mean change of −7527 ± 18,021 IU/wk, P = 0.003), whereas the epoetin dose essentially did not change for patients in the control group (mean change of 649 ± 19,987 IU/wk, P = 0.809). Mean hemoglobin, TSAT, and serum ferritin levels remained higher in the Ferric Gluconate group than in the control group (P = 0.062, P < 0.001, and P = 0.014, respectively). Over the entire 12-wk study period (DRIVE plus DRIVE-II), the control group experienced significantly more serious adverse events than the Ferric Gluconate group (incidence rate ratio = 1.73, P = 0.041). In conclusion, Ferric Gluconate maintains hemoglobin and allows lower epoetin doses in anemic hemodialysis patients with low TSAT and ferritin levels up to 1200 ng/ml.

  • Comment on “Does Ferric Gluconate lower epoetin requirements in hemodialysis patients with high ferritin levels?”
    Nature clinical practice. Nephrology, 2008
    Co-Authors: Daniel W Coyne, J Richard Trout, Toros Kapoian
    Abstract:

    Comment on “Does Ferric Gluconate lower epoetin requirements in hemodialysis patients with high ferritin levels?”

  • Results of an anemia management program to reduce high epoetin doses by targeted use of i.v. Ferric Gluconate.
    Nephrology nursing journal : journal of the American Nephrology Nurses' Association, 2008
    Co-Authors: Daniel W Coyne, Andrea Sims, Brenda Bingel
    Abstract:

    Intravenous (i.v.) iron and erythropoiesis-stimulating agents (ESAs) are important therapies in the management of anemia in patients on hemodialysis. However, there is a consensus that ESAs need to be used judiciously--a result of mounting evidence reporting increased risks when targeting higher hemoglobin (Hb) levels with higher ESA doses. Adding i.v. iron to an ESA regimen can be a cost-effective strategy to improve Hb levels and reduce ESA doses, as observed in the Dialysis Patients' Response to i.v. Iron with Elevated Ferritin (DRIVE) study. In the authors' dialysis facility, lessons learned from DRIVE were applied to the facility's anemia management program. An i.v. iron-loading dose of 500 mg to 1,000 mg of sodium Ferric Gluconate for patients on hemodialysis receiving at least 18,000 units/week of Epoetin, had a serum ferritin less than 1,500 ng/mL and a transferrin saturation (TSAT) less than 30%, and had not received a loading dose of i.v. iron in the previous 6 months was considered As a result, it was observed that a 1 gram course of Ferric Gluconate appears to be a cost-effective way to improve Hb and TSAT levels and reduce Epoetin doses, without a significant increase in serum ferritin.

Steven Fishbane - One of the best experts on this subject based on the ideXlab platform.

  • safety of intravenous iron in hemodialysis longer term comparisons of iron sucrose versus sodium Ferric Gluconate complex
    American Journal of Kidney Diseases, 2017
    Co-Authors: Wolfgang C Winkelmayer, Benjamin A Goldstein, Aya A Mitani, Victoria Y Ding, Medha Airy, Sreedhar Mandayam, Tara I Chang, Alan M Brookhart, Steven Fishbane
    Abstract:

    Background Controversy exists about any differences in longer-term safety across different intravenous iron formulations routinely used in hemodialysis (HD) patients. We exploited a natural experiment to compare outcomes of patients initiating HD therapy in facilities that predominantly (in ≥90% of their patients) used iron sucrose versus sodium Ferric Gluconate complex. Study Design Retrospective cohort study of incident HD patients. Setting & Participants Using the US Renal Data System, we hard-matched on geographic region and center characteristics HD facilities predominantly using Ferric Gluconate with similar ones using iron sucrose. Subsequently, incident HD patients were assigned to their facility iron formulation exposure. Intervention Facility-level use of iron sucrose versus Ferric Gluconate. Outcomes Patients were followed up for mortality from any, cardiovascular, or infectious causes. Medicare-insured patients were followed up for infectious and cardiovascular (stroke or myocardial infarction) hospitalizations and for composite outcomes with the corresponding cause-specific deaths. Measurements HRs. Results We matched 2,015 iron sucrose facilities with 2,015 Ferric Gluconate facilities, in which 51,603 patients (iron sucrose, 24,911; Ferric Gluconate, 26,692) subsequently initiated HD therapy. All recorded patient characteristics were balanced between groups. Over 49,989 person-years, 10,381 deaths (3,908 cardiovascular and 1,209 infectious) occurred. Adjusted all-cause (HR, 0.98; 95% CI, 0.93-1.03), cardiovascular (HR, 0.96; 95% CI, 0.89-1.03), and infectious mortality (HR, 0.98; 95% CI, 0.86-1.13) did not differ between iron sucrose and Ferric Gluconate facilities. Among Medicare beneficiaries, no differences between Ferric Gluconate and iron sucrose facilities were observed in fatal or nonfatal cardiovascular events (HR, 1.01; 95% CI, 0.93-1.09). The composite infectious end point occurred less frequently in iron sucrose versus Ferric Gluconate facilities (HR, 0.92; 95% CI, 0.88-0.96). Limitations Unobserved selection bias from nonrandom treatment assignment. Conclusions Patients initiating HD therapy in facilities almost exclusively using iron sucrose versus Ferric Gluconate had similar longer-term outcomes. However, there was a small decrease in infectious hospitalizations and deaths in patients dialyzing in facilities predominantly using iron sucrose. This difference may be due to residual confounding, random chance, or a causal effect.

  • Drug Insight: safety of intravenous iron supplementation with sodium Ferric Gluconate complex
    Nature clinical practice. Nephrology, 2006
    Co-Authors: Beckie Michael, Rajiv Agarwal, Steven Fishbane, Daniel W Coyne, David G. Warnock
    Abstract:

    Optimal management of anemia in patients with end-stage renal disease on hemodialysis usually demands intravenous iron supplementation. Michael et al. review the current safety data for the nondextran intravenous iron formulation sodium Ferric Gluconate complex, and examine the emerging concerns related to use of intravenous iron, including the risks of infection, oxidative stress and cell toxicity. Intravenous iron is necessary for optimal management of anemia in patients receiving hemodialysis and is utilized in the majority of these patients in the US. The availability of nondextran formulations of intravenous iron has significantly improved the safety of its use. The nondextran iron formulation sodium Ferric Gluconate complex (SFGC) has been extensively studied in the hemodialysis population, with two large phase IV trials documenting its safety. SFGC is efficacious and, at recommended doses, is associated with a low incidence of adverse events. There have been few comparative studies of the nondextran intravenous iron preparations; however, they are known to have different pharmacokinetic characteristics. There is also evidence to indicate that these compounds differ in terms of their cytotoxic and proinflammatory properties, and their propensity to induce oxidative stress. This paper reviews the current literature on the safety of SFGC and examines the emerging safety issues surrounding the use of intravenous iron.

  • sodium Ferric Gluconate complex in hemodialysis patients ii adverse reactions in iron dextran sensitive and dextran tolerant patients
    Kidney International, 2003
    Co-Authors: Daniel W Coyne, Rajiv Agarwal, Steven Fishbane, Allen R Nissenson, Beckie Michael, Vaughn W Folkert, Joseph W Eschbach, Franklin N Adkinson, Daniel Batlle, Richard J Trout
    Abstract:

    Sodium Ferric Gluconate complex in hemodialysis patients. II. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients. Background Iron dextran administration is associated with a high incidence of adverse reactions including anaphylaxis and death. Although dextran, rather than iron, is believed to be the cause of these reactions, it is not known whether iron dextran-sensitive patients can be safely administered another form of parenteral iron, sodium Ferric Gluconate in sucrose (SFGC). Methods In a 69 center, prospective, double-blind, controlled trial of safety and tolerability of SFGC, the rate of reactions to SFGC and placebo in 144 iron dextran-sensitive patients was compared with 2194 patients who were previously tolerant to iron dextran preparations. Serum tryptase levels, a marker of mast cell degranulation, also were measured. Results Among 143 iron dextran-sensitive patients exposed to SFGC, three (2.1%) were intolerant. All three had suspected allergic events to SFGC, including one patient with a serious reaction (0.7%). One dextran-sensitive patient (0.7%) had a suspected allergic reaction after placebo. In contrast, among 2194 iron dextran-tolerant patients, reactions to SFGC were significantly less common, with SFGC intolerance seen in seven patients (0.3%; P = 0.020), including five (0.2%) who had suspected allergic events ( P = 0.010), but none who had serious events (0.0%; P = 0.061). Two iron dextran-tolerant patients (0.09%) had allergic-like reactions following placebo injections. Two of the three suspected allergic events in the iron dextran-sensitive group were confirmed as mast cell dependent by a 100% increase in serum tryptase, while there were no confirmed allergic events in the iron dextran-tolerant group. Long-term exposure to SFGC in iron dextran-sensitive patients resulted in intolerance in only one additional patient and no serious adverse events. Conclusions Patients with a history of iron dextran sensitivity had approximately sevenfold higher rates of reaction to both placebo and SFGC compared to iron dextran tolerant patients. However, logistic regression analysis, performed to account for the higher reaction rate to placebo, suggests that this increased reactivity was not drug-specific nor immunologically mediated, but represented host idiosyncrasy. These results support the conclusions that reactions to SFGC can be attributed to pseudoallergy, and that SFGC is not a true allergen.

  • Safety in iron management.
    American journal of kidney diseases : the official journal of the National Kidney Foundation, 2003
    Co-Authors: Steven Fishbane
    Abstract:

    Intravenous (IV) iron therapy has become an integral part of hemodialysis management during the past several decades, and the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative guidelines recognize that most patients undergoing hemodialysis will require IV iron therapy on a regular basis to reach target hemoglobin (Hgb) levels. There now are three IV iron compounds available in the United States: iron dextran, sodium Ferric Gluconate, and iron sucrose. Although all have been proven effective for increasing Hgb/hematocrit levels, recent data show differences in their relative safety profiles. During the past two decades, more than 30 deaths have been attributed to the use of IV iron dextran. The two newer compounds available in the United States, sodium Ferric Gluconate and iron sucrose, have more favorable safety profiles, with the largest prospective safety comparison to date showing sodium Ferric Gluconate to be similar to placebo in the incidence of serious anaphylactoid-type reactions. This article reviews safety data surrounding the IV iron therapies.

  • sodium Ferric Gluconate complex in hemodialysis patients adverse reactions compared to placebo and iron dextran
    Kidney International, 2002
    Co-Authors: Beckie Michael, Rajiv Agarwal, Steven Fishbane, Daniel W Coyne, Allen R Nissenson, Vaughn W Folkert, Robert I Lynn, Joseph W Eschbach, Stephen Z Fadem, Richard J Trout
    Abstract:

    Sodium Ferric Gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran. Background Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores. Until recently, the only available form of intravenous iron was iron dextran, which is associated with significant adverse reactions, including anaphylaxis and death. Sodium Ferric Gluconate complex (SFGC) was recently approved for use in the U.S. under FDA's priority drug review. This Phase IV study was designed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control. Methods This multicenter, crossover, randomized, double blind, placebo-controlled prospective comparative study was performed in hemodialysis patients requiring at least 125mg of elemental iron. The historical control was obtained from a meta-analysis of four publications examining outcomes in patients exposed to iron dextran. SFGC naive patients were administered SFGC without a test dose, undiluted, at a rate of 125mg over 10 minutes, and compared to placebo comprising bacteriostatic saline. Results A total of 2534 patients were enrolled. The incidence of drug intolerance (an adverse event precluding re-exposure) was significantly less [0.44%, confidence interval (CI) 0.21 to 0.71%] after SFGC as compared to the iron dextran control (2.47%, CI 1.87 to 3.07%, P Conclusion SFGC is well tolerated when given by intravenous push without a test dose. SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran. The routine use of iron dextran in hemodialysis patients should be discontinued.

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  • Proteinuria Induced by Parenteral Iron in Chronic Kidney Disease—A Comparative Randomized Controlled
    2016
    Co-Authors: Rajiv Agarwal, David J. Leehey, Scott M. Olsen, Naomi V Dahl
    Abstract:

    Background and objectives Among patients with chronic kidney disease (CKD), differences in proteinuria are seen between intravenous iron preparations after a single dose exposure. This study examined differ-ences in proteinuria between two intravenous iron preparations after multiple doses. Design, setting, participants, & measurements Patients with iron-deficiency anemia and CKD, stratified by angiotensin converting enzyme inhibitor (ACEI)/angiotensin receptor-blocker (ARB) use, were randomized to iron sucrose or Ferric Gluconate. Each patient at 12 centers received 100 mg of study drug weekly for 5 weeks. Urine protein/urine creatinine ratio was measured before each dose and frequently thereafter for 3 hours. Results Postbaseline data were available from 33 patients receiving iron sucrose and 29 patients receiving Ferric Gluconate. Although neither preparation of intravenous iron increased the predose level of protein-uria, the proteinuric response to intravenous iron was dependent on the type of iron and ACEI/ARB use. Without ACEIs/ARBs, Ferric Gluconate tended to cause less proteinuria with repeated iron administration; iron sucrose did not mitigate or aggravate proteinuria. Among patients receiving ACEIs/ARBs, in contrast to Ferric Gluconate, which produced only mild transient proteinuria, iron sucrose produced a consistent and persistent proteinuric response that was on average 78 % greater. Conclusions Although multiple doses of either intravenous iron did not increase basal levels of proteinuria, postdose proteinuria was greater with iron sucrose than with Ferric Gluconate. These data suggest that nephrotoxicity of iron may depend on type of intravenous iron and on ACEI/ARB use. The long-term ef-fects on kidney function need to be further evaluated

  • Proteinuria Induced by Parenteral Iron in Chronic Kidney Disease—A Comparative Randomized Controlled Trial
    Clinical journal of the American Society of Nephrology : CJASN, 2010
    Co-Authors: Rajiv Agarwal, David J. Leehey, Scott M. Olsen, Naomi V Dahl
    Abstract:

    Summary Background and objectives Among patients with chronic kidney disease (CKD), differences in proteinuria are seen between intravenous iron preparations after a single dose exposure. This study examined differences in proteinuria between two intravenous iron preparations after multiple doses. Design, setting, participants, & measurements Patients with iron-deficiency anemia and CKD, stratified by angiotensin converting enzyme inhibitor (ACEI)/angiotensin receptor-blocker (ARB) use, were randomized to iron sucrose or Ferric Gluconate. Each patient at 12 centers received 100 mg of study drug weekly for 5 weeks. Urine protein/urine creatinine ratio was measured before each dose and frequently thereafter for 3 hours. Results Postbaseline data were available from 33 patients receiving iron sucrose and 29 patients receiving Ferric Gluconate. Although neither preparation of intravenous iron increased the predose level of proteinuria, the proteinuric response to intravenous iron was dependent on the type of iron and ACEI/ARB use. Without ACEIs/ARBs, Ferric Gluconate tended to cause less proteinuria with repeated iron administration; iron sucrose did not mitigate or aggravate proteinuria. Among patients receiving ACEIs/ARBs, in contrast to Ferric Gluconate, which produced only mild transient proteinuria, iron sucrose produced a consistent and persistent proteinuric response that was on average 78% greater. Conclusions Although multiple doses of either intravenous iron did not increase basal levels of proteinuria, postdose proteinuria was greater with iron sucrose than with Ferric Gluconate. These data suggest that nephrotoxicity of iron may depend on type of intravenous iron and on ACEI/ARB use. The long-term effects on kidney function need to be further evaluated.

  • author s response to comment on does Ferric Gluconate lower epoetin requirements in hemodialysis patients with high ferritin levels
    Nature Reviews Nephrology, 2008
    Co-Authors: Rajiv Agarwal
    Abstract:

    Author's response to “Comment on “Does Ferric Gluconate lower epoetin requirements in hemodialysis patients with high ferritin levels?””

  • Author's response to “Comment on “Does Ferric Gluconate lower epoetin requirements in hemodialysis patients with high ferritin levels?””
    Nature Clinical Practice Nephrology, 2008
    Co-Authors: Rajiv Agarwal
    Abstract:

    Author's response to “Comment on “Does Ferric Gluconate lower epoetin requirements in hemodialysis patients with high ferritin levels?””

  • iron sucrose causes greater proteinuria than Ferric Gluconate in non dialysis chronic kidney disease
    Kidney International, 2007
    Co-Authors: Rajiv Agarwal, A R Rizkala, M O Kaskas, R Minasian, J R Trout
    Abstract:

    Non-dextran intravenous (i.v.) iron preparations seem to differentially affect proteinuria in patients with chronic kidney disease. To study effects of Ferric Gluconate and iron sucrose on proteinuria, we conducted a crossover trial in 12 patients with stage 3–4 chronic kidney disease. These patients were randomized to receive the same dose of either drug 1 week apart. Urine samples were obtained immediately before and at frequent intervals after the drug. The urine total protein/creatinine ratio was significantly greater after iron sucrose than Ferric Gluconate treatment with the effect noted within 15 min post-infusion. Furthermore, when iron sucrose was given first, a significantly greater protein/creatinine ratio was seen subsequently with Ferric Gluconate than with the reverse order of treatment. The urine albumin/creatinine ratio was also significantly greater with iron sucrose than with Ferric Gluconate. There was no significant difference, however, between the two i.v. irons in the measured urine N -acetyl- β -D-glucosaminidase/creatinine ratio. Although our study showed that acutely, iron sucrose increased proteinuria, the long-term effects of repeated i.v. non-dextran iron on kidney function requires further study.