The Experts below are selected from a list of 5670 Experts worldwide ranked by ideXlab platform
Barry D Kahan - One of the best experts on this subject based on the ideXlab platform.
-
the selective use of Basiliximab versus thymoglobulin in combination with sirolimus for cadaveric renal transplant recipients at low risk versus high risk for delayed graft function
Transplantation, 2004Co-Authors: Richard J Knight, R H Kerman, L Schoenberg, Hemangshu Podder, Charles T Van Buren, Stephen M Katz, Barry D KahanAbstract:Background. We previously reported that the use of Basiliximab together with sirolimus permits a window of recovery from delayed graft function before the introduction of reduced-dose cyclosporine. The present study reviews our experience with the substitution of thymoglobulin for Basiliximab as induction therapy for recipients at increased risk for early acute rejection episodes. Methods. We retrospectively reviewed 145 cadaveric renal allograft recipients who received either Basiliximab (n = 115) or thymoglobulin (n = 30) in combination with sirolimus and prednisone, followed by delayed introduction of reduced doses of cyclosporine. Recipients were stratified as high immune responders if they were African American, a retransplant recipient, or a recipient with a panel-reactive antibody greater than 50%. All other recipients were considered low immune responders. Results. Basiliximab-treated high immune responders exhibited a higher incidence of acute rejection episodes (26%) than either Basiliximab-treated low immune responders (10%, P=0.04) or thymoglobulin-treated high immune responders (3%, P=0.01). The median time to initiation of cyclosporine was 12 days; cyclosporine was initiated when the serum creatinine level was 2.5 mg/dL or less. Patients with early return of renal function displayed a lower incidence of acute rejection episodes than those with later recovery of function (P=0.003). High immune responders treated with Basiliximab expressed a higher mean serum creatinine level at 3 months (P<0.01), 6 months (P=0.02) and 12 months (P=0.01) than either low immune responders treated with Basiliximab or high immune responders treated with thymoglobulin. Conclusion. A strategy combining sirolimus with Basiliximab for low-immunologic risk recipients and thymoglobulin for high-risk recipients leads to prompt recovery of renal function with a low risk of acute rejection episodes.
-
population pharmacokinetics and exposure response relationships for Basiliximab in kidney transplantation
Transplantation, 1999Co-Authors: John M. Kovarik, Barry D Kahan, P R Rajagopalan, William M Bennett, Laura L Mulloy, C Gerbeau, M HallAbstract:BACKGROUND: Basiliximab is an interleukin-2 receptor (CD25) chimeric monoclonal antibody used for acute rejection prophylaxis in renal transplants. In the context of a randomized, double-blind efficacy trial, its population pharmacokinetics and potential exposure-response relationships were explored in de novo kidney allograft recipients receiving 40 mg Basiliximab (20 mg on days 0 and 4) in addition to baseline immunosuppressive therapy with cyclosporine microemulsion and corticosteroids. METHODS: Serial blood samples (8.2+/-1.3 per patient) were collected over 12 weeks after transplant from 169 Basiliximab-treated patients, and empirical Bayes estimates of each patient's disposition parameters were derived. The duration of CD25 saturation was estimated as the time over which serum Basiliximab concentrations exceeded 0.2 microg/ml. The relationships between pharmacokinetic parameters and demographic-clinical covariates were explored by regression methods and unpaired t-tests. RESULTS: Basiliximab clearance was 36.7+/-15.2 ml/hr, distribution volume 8.0+/-2.4 L, and half life 7.4+/-3.0 days. Patient weight (range, 44-131 kg) and age (range, 20-69 yrs) each contributed < or =6% to the variability in clearance and volume. Gender, ethnic group, and the presence of proteinuria had no clinically relevant influences on Basiliximab disposition. Receptor-saturating Basiliximab concentrations were maintained for 36+/-14 days (range, 12-91). There was no apparent relationship between the incidence or day of onset of acute rejection episodes during CD25 saturation and Basiliximab concentration (range, 0.2-5.0 microg/ml). In patients who experienced a rejection episode after Basiliximab was eliminated from serum (n=33), Basiliximab had not been cleared faster than in their rejection-free peers (P=0.322) nor had CD25 been saturated for a shorter period of time (33+/-13 days vs. 37+/-14 days for rejection-free patients, P=0.162). CONCLUSIONS: There were no demographic or clinical subpopulations not adequately treated with the standard Basiliximab dosing regimen. Over the range of CD25 suppression durations observed in this study, extended periods of receptor blockade did not seem to confer an immunoprophylactic advantage compared with shorter periods of receptor suppression.
-
reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with Basiliximab a chimeric anti interleukin 2 receptor monoclonal antibody united states simulect renal study group
Transplantation, 1999Co-Authors: Barry D Kahan, P R Rajagopalan, Michael HallAbstract:Background. A double-blind, placebo-controlled phase III study was performed to assess whether Basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. Methods. A total of 348 patients were randomized into two demographically matched, equally sized groups treated with either Basiliximab or placebo. The dose of Basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of interleukin-2 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All patients received immunosuppressive therapy with cyclosporine microemulsion (Neoral®) and steroids. An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, patient and graft survival rates, and the safety and tolerability of Basiliximab. Results. Among the eligible 346 patients equally divided into the two treatment groups, Basiliximab reduced the proportion of patients who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) Basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) Basiliximab-treated and 12 (6.9%) placebo-treated patients. Five (2.9%) deaths in the Basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of Basiliximab patients produced urine in the operating room, and a significantly lower fraction had renal dysfunction in the first month (serum creatinine 3 mg/dl). During the first 12 months, 94 (54%) Basiliximab-treated patients experienced serious adverse events, compared with 106 (61%) who received placebo. Conclusions. Prophylactic Basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft patients within the first year after transplantation.
-
reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with Basiliximab a chimeric anti interleukin 2 receptor monoclonal antibody united states simulect renal study group
Transplantation, 1999Co-Authors: Barry D Kahan, P R Rajagopalan, Michael HallAbstract:BACKGROUND: A double-blind, placebo-controlled phase III study was performed to assess whether Basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. METHODS: A total of 348 patients were randomized into two demographically matched, equally sized groups treated with either Basiliximab or placebo. The dose of Basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of interleukin-2 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All patients received immunosuppressive therapy with cyclosporine microemulsion (Neoral) and steroids. An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, patient and graft survival rates, and the safety and tolerability of Basiliximab. RESULTS: Among the eligible 346 patients equally divided into the two treatment groups, Basiliximab reduced the proportion of patients who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) Basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) Basiliximab-treated and 12 (6.9%) placebo-treated patients. Five (2.9%) deaths in the Basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of Basiliximab patients produced urine in the operating room, and a significantly lower fraction had renal dysfunction in the first month (serum creatinine > or =5 mg(dl) and between 1 and 12 months (serum creatinine > or =3 mg/dl). During the first 12 months, 94 (54%) Basiliximab-treated patients experienced serious adverse events, compared with 106 (61%) who received placebo. CONCLUSIONS: Prophylactic Basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft patients within the first year after transplantation.
Michael Hall - One of the best experts on this subject based on the ideXlab platform.
-
reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with Basiliximab a chimeric anti interleukin 2 receptor monoclonal antibody united states simulect renal study group
Transplantation, 1999Co-Authors: Barry D Kahan, P R Rajagopalan, Michael HallAbstract:Background. A double-blind, placebo-controlled phase III study was performed to assess whether Basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. Methods. A total of 348 patients were randomized into two demographically matched, equally sized groups treated with either Basiliximab or placebo. The dose of Basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of interleukin-2 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All patients received immunosuppressive therapy with cyclosporine microemulsion (Neoral®) and steroids. An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, patient and graft survival rates, and the safety and tolerability of Basiliximab. Results. Among the eligible 346 patients equally divided into the two treatment groups, Basiliximab reduced the proportion of patients who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) Basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) Basiliximab-treated and 12 (6.9%) placebo-treated patients. Five (2.9%) deaths in the Basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of Basiliximab patients produced urine in the operating room, and a significantly lower fraction had renal dysfunction in the first month (serum creatinine 3 mg/dl). During the first 12 months, 94 (54%) Basiliximab-treated patients experienced serious adverse events, compared with 106 (61%) who received placebo. Conclusions. Prophylactic Basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft patients within the first year after transplantation.
-
reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with Basiliximab a chimeric anti interleukin 2 receptor monoclonal antibody united states simulect renal study group
Transplantation, 1999Co-Authors: Barry D Kahan, P R Rajagopalan, Michael HallAbstract:BACKGROUND: A double-blind, placebo-controlled phase III study was performed to assess whether Basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. METHODS: A total of 348 patients were randomized into two demographically matched, equally sized groups treated with either Basiliximab or placebo. The dose of Basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of interleukin-2 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All patients received immunosuppressive therapy with cyclosporine microemulsion (Neoral) and steroids. An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, patient and graft survival rates, and the safety and tolerability of Basiliximab. RESULTS: Among the eligible 346 patients equally divided into the two treatment groups, Basiliximab reduced the proportion of patients who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) Basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) Basiliximab-treated and 12 (6.9%) placebo-treated patients. Five (2.9%) deaths in the Basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of Basiliximab patients produced urine in the operating room, and a significantly lower fraction had renal dysfunction in the first month (serum creatinine > or =5 mg(dl) and between 1 and 12 months (serum creatinine > or =3 mg/dl). During the first 12 months, 94 (54%) Basiliximab-treated patients experienced serious adverse events, compared with 106 (61%) who received placebo. CONCLUSIONS: Prophylactic Basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft patients within the first year after transplantation.
P R Rajagopalan - One of the best experts on this subject based on the ideXlab platform.
-
population pharmacokinetics and exposure response relationships for Basiliximab in kidney transplantation
Transplantation, 1999Co-Authors: John M. Kovarik, Barry D Kahan, P R Rajagopalan, William M Bennett, Laura L Mulloy, C Gerbeau, M HallAbstract:BACKGROUND: Basiliximab is an interleukin-2 receptor (CD25) chimeric monoclonal antibody used for acute rejection prophylaxis in renal transplants. In the context of a randomized, double-blind efficacy trial, its population pharmacokinetics and potential exposure-response relationships were explored in de novo kidney allograft recipients receiving 40 mg Basiliximab (20 mg on days 0 and 4) in addition to baseline immunosuppressive therapy with cyclosporine microemulsion and corticosteroids. METHODS: Serial blood samples (8.2+/-1.3 per patient) were collected over 12 weeks after transplant from 169 Basiliximab-treated patients, and empirical Bayes estimates of each patient's disposition parameters were derived. The duration of CD25 saturation was estimated as the time over which serum Basiliximab concentrations exceeded 0.2 microg/ml. The relationships between pharmacokinetic parameters and demographic-clinical covariates were explored by regression methods and unpaired t-tests. RESULTS: Basiliximab clearance was 36.7+/-15.2 ml/hr, distribution volume 8.0+/-2.4 L, and half life 7.4+/-3.0 days. Patient weight (range, 44-131 kg) and age (range, 20-69 yrs) each contributed < or =6% to the variability in clearance and volume. Gender, ethnic group, and the presence of proteinuria had no clinically relevant influences on Basiliximab disposition. Receptor-saturating Basiliximab concentrations were maintained for 36+/-14 days (range, 12-91). There was no apparent relationship between the incidence or day of onset of acute rejection episodes during CD25 saturation and Basiliximab concentration (range, 0.2-5.0 microg/ml). In patients who experienced a rejection episode after Basiliximab was eliminated from serum (n=33), Basiliximab had not been cleared faster than in their rejection-free peers (P=0.322) nor had CD25 been saturated for a shorter period of time (33+/-13 days vs. 37+/-14 days for rejection-free patients, P=0.162). CONCLUSIONS: There were no demographic or clinical subpopulations not adequately treated with the standard Basiliximab dosing regimen. Over the range of CD25 suppression durations observed in this study, extended periods of receptor blockade did not seem to confer an immunoprophylactic advantage compared with shorter periods of receptor suppression.
-
reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with Basiliximab a chimeric anti interleukin 2 receptor monoclonal antibody united states simulect renal study group
Transplantation, 1999Co-Authors: Barry D Kahan, P R Rajagopalan, Michael HallAbstract:Background. A double-blind, placebo-controlled phase III study was performed to assess whether Basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. Methods. A total of 348 patients were randomized into two demographically matched, equally sized groups treated with either Basiliximab or placebo. The dose of Basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of interleukin-2 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All patients received immunosuppressive therapy with cyclosporine microemulsion (Neoral®) and steroids. An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, patient and graft survival rates, and the safety and tolerability of Basiliximab. Results. Among the eligible 346 patients equally divided into the two treatment groups, Basiliximab reduced the proportion of patients who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) Basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) Basiliximab-treated and 12 (6.9%) placebo-treated patients. Five (2.9%) deaths in the Basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of Basiliximab patients produced urine in the operating room, and a significantly lower fraction had renal dysfunction in the first month (serum creatinine 3 mg/dl). During the first 12 months, 94 (54%) Basiliximab-treated patients experienced serious adverse events, compared with 106 (61%) who received placebo. Conclusions. Prophylactic Basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft patients within the first year after transplantation.
-
reduction of the occurrence of acute cellular rejection among renal allograft recipients treated with Basiliximab a chimeric anti interleukin 2 receptor monoclonal antibody united states simulect renal study group
Transplantation, 1999Co-Authors: Barry D Kahan, P R Rajagopalan, Michael HallAbstract:BACKGROUND: A double-blind, placebo-controlled phase III study was performed to assess whether Basiliximab, a chimeric anti-interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection episodes in renal allograft recipients. METHODS: A total of 348 patients were randomized into two demographically matched, equally sized groups treated with either Basiliximab or placebo. The dose of Basiliximab-20-mg infusions on day 0 and day 4-was selected to block detection of interleukin-2 receptor on 97% of peripheral blood lymphocytes for 30-45 days. All patients received immunosuppressive therapy with cyclosporine microemulsion (Neoral) and steroids. An intent-to-treat analysis of 1-year data assessed the incidence of posttransplant acute rejection episodes, patient and graft survival rates, and the safety and tolerability of Basiliximab. RESULTS: Among the eligible 346 patients equally divided into the two treatment groups, Basiliximab reduced the proportion of patients who experienced biopsy-confirmed acute rejection episodes by 28%: 61 (35.3%) Basiliximab vs. 85 (49.1%) placebo (P=0.009). Graft losses occurred in 9 (5.2%) Basiliximab-treated and 12 (6.9%) placebo-treated patients. Five (2.9%) deaths in the Basiliximab group and seven (4.0%) in the placebo group occurred. Compared with placebo, a higher fraction of Basiliximab patients produced urine in the operating room, and a significantly lower fraction had renal dysfunction in the first month (serum creatinine > or =5 mg(dl) and between 1 and 12 months (serum creatinine > or =3 mg/dl). During the first 12 months, 94 (54%) Basiliximab-treated patients experienced serious adverse events, compared with 106 (61%) who received placebo. CONCLUSIONS: Prophylactic Basiliximab therapy is well tolerated, has an adverse event profile comparable to placebo, and significantly reduces the number of acute rejection episodes in renal allograft patients within the first year after transplantation.
Mark S Cattral - One of the best experts on this subject based on the ideXlab platform.
-
thymoglobulin versus Basiliximab induction therapy for simultaneous kidney pancreas transplantation impact on rejection graft function and long term outcome
Transplantation, 2011Co-Authors: Fateh Bazerbachi, Markus Selzner, Markus U Boehnert, Max Marquez, Andrea Norgate, Ian D Mcgilvray, Jeffrey Schiff, Mark S CattralAbstract:BACKGROUND: Thymoglobulin (ATG) and Basiliximab induction therapies are used by the majority of centers for pancreas transplantation today. Although both strategies have different mechanisms, there is a paucity of studies comparing them. We compared the efficacy and side effects of both methods in simultaneous pancreas-kidney (SPK) transplantation. METHODS: We analyzed 128 SPKs at our institution between January 2001 and August 2008. Forty-nine patients received Basiliximab (40 mg), whereas 79 patients had ATG (5 mg/kg). Graft function, complications, rejection, and survival rates were analyzed. RESULTS: ATG versus Basiliximab therapy was associated with decreased 3-month (6% vs. 21%; P=0.01) and 1-year (14% vs. 27%; P=0.049) rejection rate. Steroid-resistant rejections were decreased with ATG (3%) vs. Basiliximab (14%) (P=0.01). In a univariate regression analysis, Basiliximab induction was a risk factor for rejection (HR, 7.1; CI, 3.8-13). No differences were observed regarding complications and graft function up to 5 years. ATG versus Basiliximab therapy resulted in identical 1-year (90% vs. 93%), 3-year (87% vs. 89%), and 5-year (78% vs. 83%) pancreas survival (P=0.7). No difference was observed in kidney survival after 1 year (99% vs. 98%), 3 years (97% vs. 98%), and 5 years (95% vs. 95%) (P=0.4). CONCLUSIONS: ATG versus Basiliximab induction therapy results in decreased acute cellular rejection in the first year after SPK with similar side effects. Long-term graft function and survival are not affected by induction regimen.
Johan Nilsson - One of the best experts on this subject based on the ideXlab platform.
-
comparison of Basiliximab and anti thymocyte globulin as induction therapy in pediatric heart transplantation a survival analysis
Journal of the American Heart Association, 2016Co-Authors: David Ansari, Peter Hoglund, Bodil Andersson, Johan NilssonAbstract:Background Basiliximab and anti‐thymocyte globulin are widely used drugs for induction therapy after pediatric heart transplantation. The aim of this study was to determine whether any differences could be observed between Basiliximab and anti‐thymocyte globulin, with respect to long‐term mortality, in a population of pediatric cardiac transplant recipients. Methods and Results An analysis of pediatric heart transplant patients (aged <18 years) from the United Network for Organ Sharing database was conducted that compared patients receiving Basiliximab with those that received anti‐thymocyte globulin for the risk of all‐cause mortality. Secondary endpoints included death attributable to graft failure, cardiovascular causes, infection, or malignancy. Of the 2275 patients, 685 received Basiliximab and 1590 anti‐thymocyte globulin. One‐year survival was similar for both groups; however, at 5 and 10 years, Basiliximab was associated with poorer long‐term survival (68% versus 76% at 5 years [ P <0.001] and 49% versus 65% at 10 years [ P <0.001], respectively). Basiliximab was associated with higher risk of death attributable to graft failure ( P =0.013), but not death attributable to cardiovascular causes ( P =0.444), infection ( P =0.095), or malignancy ( P =0.392). After multivariate analysis, use of Basiliximab (versus use of anti‐thymocyte globulin) remained significantly associated with all‐cause mortality (hazard ratio, 1.27; 95% confidence interval, 1.02–1.57; P =0.030). Conclusions In pediatric heart transplant patients, use of Basiliximab for induction therapy was associated with an increased risk of mortality, when compared with those receiving anti‐thymocyte globulin.
-
Comparison of Basiliximab and Anti-Thymocyte Globulin as Induction Therapy in Pediatric Heart Transplantation: A Survival Analysis.
Journal of the American Heart Association, 2015Co-Authors: David Ansari, Peter Hoglund, Bodil Andersson, Johan NilssonAbstract:Background Basiliximab and anti‐thymocyte globulin are widely used drugs for induction therapy after pediatric heart transplantation. The aim of this study was to determine whether any differences could be observed between Basiliximab and anti‐thymocyte globulin, with respect to long‐term mortality, in a population of pediatric cardiac transplant recipients. Methods and Results An analysis of pediatric heart transplant patients (aged
