Estudios primarios incluidos en esta revisión sistemática

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Estudio primario

No clasificado

Induction therapy with rabbit antithymocyte globulin versus basiliximab after kidney transplantation: a health economic analysis from a German perspective.

Revista Transplant international : official journal of the European Society for Organ Transplantation
Año 2017
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Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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A health economic analysis was undertaken based on the 1-year database from a randomized study of rabbit anti-human thymocyte immunoglobulin (rATG) versus basiliximab, in kidney transplantation using resource utilization data and cost estimates from three German hospitals. A three-state Markov model was applied to estimate cost-effectiveness to 10 years post-transplant. Total mean treatment cost per patient to year 1 post-transplant was €62 075 vs. €59 767 for rATG versus basiliximab (P < 0.01). rATG therapy was associated with similar treatment costs to basiliximab by year 2, and a predicted cumulative treatment cost saving of €4 259 under rATG versus basiliximab by year 10 post-transplant. The mean number of quality-adjusted life years (QALYs) per patient by year 1 was 0.809 vs. 0.802 in the rATG and basiliximab cohorts, respectively (P = 0.38), with cumulative QALYs of 6.161 and 6.065 per patient by year 10. By year 2, the cumulative cost per QALY was slightly lower under rATG (€35 378) than basiliximab (€35 885), progressing to a saving of €1 041 under rATG for the cumulative cost per QALY by year 10. In conclusion, this model indicates that rATG induction provides a modest increase in QALYs with lower long-term costs than basiliximab in deceased-donor high-risk kidney transplant patients.

Estudio primario

No clasificado

Anti-B cell therapy with rituximab as induction therapy in renal transplantation.

Revista Transplant immunology
Año 2014
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Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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Traditionally, antirejection therapy in organ transplantation has mainly been directed at T cells. During recent years, the role of B cells in acute rejection has attracted more attention. In the Radboud University Medical Center (Nijmegen, The Netherlands) we performed a randomized, placebo controlled study to assess the efficacy and safety of rituximab as induction therapy after renal transplantation. In parallel we investigated the effects of rituximab on the numbers and function of B and T cells. An overview of the results, which have largely been published in peer reviewed papers, is presented below.

Hilo de publicación

Ciancio et al [provisional name] (Tacrolimus, mycophenolate mofetil, and steroid dosing to prevent acute renal allograft rejection [provisional name])

Este hilo de publicación incluye 8 referencias

Hilo de publicación

3C Study

Este hilo de publicación incluye 1 referencias

Estudio primario

No clasificado

Alemtuzumab induction therapy in highly sensitized kidney transplant recipients.

Autores Lü TM , Yang SL , Wu WZ , Tan JM
Revista Chinese medical journal
Año 2011
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Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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BACKGROUND: Immunosuppression for immunologically high-risk kidney transplant patients usually involves antithymocyte globulin induction with triple drug maintenance therapy. Alemtuzumab, a humanized anti-CD52 antibody, was expected to be a promising induction therapy agent for kidney transplantation. However, currently no consensus is available about its efficacy and safety. This study aimed to evaluate the efficacy and safety of alemtuzumab as immune induction therapy in highly sensitized kidney transplant recipients. METHODS: In this prospective, open-label, randomized, controlled trial, we enrolled 23 highly immunological risk patients (panel reactive antibody > 20%). They were divided into two groups: alemtuzumab group (trial group) and anti-thymocyte globulin (ATG) group (control group). Patients in the alemtuzumab group received intravenous alemtuzumab (15 mg) as a single dose before reperfusion. At the 24th hour post-operation, another dosage of alemtuzumab (15 mg) was given. The control group received a bolus of rabbit ATG (9 mg/kg), which was given 2 hours before kidney transplantation and lasted until the removal of vascular clamps when the anastomoses were completed. Maintenance immunosuppression in both groups comprised standard triple therapy consisting of tacrolimus, prednisone, and mycophenolate mofetil (MMF). Acute rejection (AR) and infection episodes were recorded, and kidney function was monitored during a 2-year follow-up. χ(2) test, t test and Kaplan-Meier analysis were performed with SPSS17.0 software. RESULTS: Median follow-up was 338 days. In both the alemtuzumab group and ATG group, creatinine and blood urea nitrogen values in surviving recipients were similar (P > 0.05). White blood cell counts were significantly reduced in the alemtuzumab group for the most time points up to 6 months (P < 0.05). One patient receiving alemtuzumab died for acute myocardial infarction at the 65th day post-operation. Two ATG patients died for severe pulmonary infection or cardiac and pulmonary failure. Cumulative 2-year graft survival rate was 90.9% in the alemtuzumab group and 81.8% in ATG group (P > 0.05) respectively. There was one graft failure in the alemtuzumab group and two graft failures in ATG group, with all graft failures at tributed to rejection episodes. The alemtuzumab group had a 2-year cumulative freedom from rejection rate of 81.8%, compared with 72.7% for the ATG group (P > 0.05). CONCLUSION: Alemtuzumab induction therapy for highly sensitized kidney transplant recipients is an effective and safe protocol yielding an acceptable acute rejection rate.

Estudio primario

No clasificado

Kidney transplantation with minimized maintenance: alemtuzumab induction with tacrolimus monotherapy--an open label, randomized trial.

Revista Transplantation
Año 2011
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Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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BACKGROUND: Immunosuppressive regimens for kidney transplantation which reduce the long-term burden of immunosuppression are attractive, but little data are available to judge the safety and efficacy of the different strategies used. We tested the hypothesis that the simple, cheap, regimen of alemtuzumab induction combined with tacrolimus monotherapy maintenance provided equivalent outcomes to the more commonly used combination of interleukin-2 receptor monoclonal antibody induction with tacrolimus and mycophenolate mofetil combination maintenance, both regimens using steroid withdrawal after 7 days. METHODS: One hundred twenty-three live or deceased donor renal transplant recipients were randomized 2:1 to receive alemtuzumab/tacrolimus or daclizumab/tacrolimus/mycophenolate. The primary endpoint was survival with a functioning graft at 1 year. RESULTS: Both regimens produced equivalent, excellent outcomes with the primary outcome measure of 97.6% in the alemtuzumab arm and 95.1% in the daclizumab arm at 1 year (95% confidence interval of difference 6.9% to -1.7%) and at 2 years 92.6% and 95.1%. Rejection was less frequent in the alemtuzumab arm with 1- and 2-year rejection-free survival of 91.2% and 89.9% compared with 82.3% and 82.3% in the daclizumab arm. There were no significant differences in terms of the occurrence of opportunistic infections. CONCLUSION: Alemtuzumab induction with tacrolimus maintenance monotherapy and short-course steroid use provides a simple, safe, and effective immunosuppressive regimen for renal transplantation.

Estudio primario

No clasificado

Alemtuzumab induction in renal transplantation.

Revista The New England journal of medicine
Año 2011
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Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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BACKGROUND: There are few comparisons of antibody induction therapy allowing early glucocorticoid withdrawal in renal-transplant recipients. The purpose of the present study was to compare induction therapy involving alemtuzumab with the most commonly used induction regimens in patient populations at either high immunologic risk or low immunologic risk. METHODS: In this prospective study, we randomly assigned patients to receive alemtuzumab or conventional induction therapy (basiliximab or rabbit antithymocyte globulin). Patients were stratified according to acute rejection risk, with a high risk defined by a repeat transplant, a peak or current value of panel-reactive antibodies of 20% or more, or black race. The 139 high-risk patients received alemtuzumab (one dose of 30 mg, in 70 patients) or rabbit antithymocyte globulin (a total of 6 mg per kilogram of body weight given over 4 days, in 69 patients). The 335 low-risk patients received alemtuzumab (one dose of 30 mg, in 164 patients) or basiliximab (a total of 40 mg over 4 days, in 171 patients). All patients received tacrolimus and mycophenolate mofetil and underwent a 5-day glucocorticoid taper in a regimen of early steroid withdrawal. The primary end point was biopsy-confirmed acute rejection at 6 months and 12 months. Patients were followed for 3 years for safety and efficacy end points. RESULTS: The rate of biopsy-confirmed acute rejection was significantly lower in the alemtuzumab group than in the conventional-therapy group at both 6 months (3% vs. 15%, P<0.001) and 12 months (5% vs. 17%, P<0.001). At 3 years, the rate of biopsy-confirmed acute rejection in low-risk patients was lower with alemtuzumab than with basiliximab (10% vs. 22%, P=0.003), but among high-risk patients, no significant difference was seen between alemtuzumab and rabbit antithymocyte globulin (18% vs. 15%, P=0.63). Adverse-event rates were similar among all four treatment groups. CONCLUSIONS: By the first year after transplantation, biopsy-confirmed acute rejection was less frequent with alemtuzumab than with conventional therapy. The apparent superiority of alemtuzumab with respect to early biopsy-confirmed acute rejection was restricted to patients at low risk for transplant rejection; among high-risk patients, alemtuzumab and rabbit antithymocyte globulin had similar efficacy. (Funded by Astellas Pharma Global Development; INTAC ClinicalTrials.gov number, NCT00113269.).

Estudio primario

No clasificado

Randomized trial of thymoglobulin versus alemtuzumab (with lower dose maintenance immunosuppression) versus daclizumab in living donor renal transplantation

Revista Transplantation proceedings
Año 2010
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Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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Background We performed a randomized trial evaluating Alemtuzumab, a humanized anti-CD52 monoclonal antibody, in living donor (LD) kidney transplantation. Methods Thirty-eight LD first renal transplant recipients were randomized into three single-agent antibody induction groups: thymoglobulin (group A); alemtuzumab (group B); and daclizumab (group C). In groups A and C, target tacrolimus trough levels were 6 to 8 ng/mL, with 1 gm mycophenolate mofetil (MMF) administered twice daily, and maintenance methylprednisolone. In group B, the target tacrolimus trough level was 4 to 6 ng/mL, with 500 mg MMF administered twice daily, without methylprednisolone. Results With 29/38 patients now followed beyond 36 months posttransplantation, we observed no graft failures and only one death with a functioning graft (in group B). Acute rejection episodes were low: 0/13, 1/13, and 1/12 patients in groups A, B, and C. Biopsy-proven chronic allograft injury was higher among group B (3/13) versus groups A (0/13) or C (0/12; P = .01). Poorer renal function was observed in group B; the mean calculated creatinine clearance at 3 months posttransplantation was significantly poorer: 63.3 ± 3.0 versus 85.4 ± 7.2 and 82.2 ± 8.2 in groups A and C (P = .01). No differences in the incidence of adverse events were observed. © 2010 by Elsevier Inc. All rights reserved.

Estudio primario

No clasificado

Un estudio aleatorizado, DoubleBlind, controlado con placebo, el estudio de dosis única de rituximab como la inducción en el trasplante renal.

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Revista Transplantation
Año 2009
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Este artículo está incluido en 3 Revisiones sistemáticas Revisiones sistemáticas (3 referencias)

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Se realizó un estudio prospectivo, doble ciego, aleatorizado, controlado con placebo y multicéntrico sobre la eficacia y seguridad de rituximab como terapia de inducción, junto con tacrolimus, micofenolato mofetil y esteroides. El punto final primario fue definido como rechazo agudo, pérdida del injerto o muerte durante los primeros 6 meses. Los puntos finales secundarios fueron el aclaramiento de creatinina, la incidencia de las infecciones, y la incidencia de rituximab relacionada con eventos adversos. RESULTADOS: Se incluyó a 140 pacientes (44 de donante vivo y 96 de un donante fallecido), y de esos, el 68 de rituximab y 68 pacientes tratados con placebo cumplido el estudio. En todos los pacientes que recibieron rituximab, hubo un agotamiento completo de CD19/CD20 células, mientras que no hubo ningún cambio en el número de CD19/CD20 células en el grupo placebo. Hubo 10 fracasos del tratamiento en el grupo de rituximab frente a 14 en el grupo placebo (p = 0,348). Hubo ocho episodios de rechazo en el grupo de rituximab frente a 12 en el grupo placebo (p = 0,317) El aclaramiento de creatinina fue de 66 + / -22 ml / min en el grupo de estudio y 67 + / -23 ml / min en el grupo placebo. No hubo diferencia en el número de infecciones bacterianas, infecciones por citomegalovirus, y las infecciones de virus BK o infecciones fúngicas. CONCLUSIÓN: Se realizó un estudio controlado con placebo de la inducción con rituximab en el trasplante renal. Hubo una tendencia hacia el rechazo de menos y más leves durante los primeros 6 meses en el grupo de rituximab. A pesar de la inducción con una dosis de rituximab induce a las células B agotamiento total, no hubo un aumento en la incidencia de complicaciones infecciosas o leucopenia y parece seguro, por lo tanto, para llevar a cabo nuevos estudios sobre el uso de rituximab en el trasplante.

Estudio primario

No clasificado

Alemtuzumab (Campath-1H) and tacrolimus monotherapy after renal transplantation: results of a prospective randomized trial.

Revista American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
Año 2008
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The lymphocyte-depleting antibody alemtuzumab was evaluated in a prospective randomized multicenter trial in deceased donor kidney transplantation. The 65 patients in the study group received induction with alemtuzumab followed by delayed tacrolimus monotherapy, while the 66 patients in the control group were started on tacrolimus in combination with mycophenolate mofetil and steroids. Tacrolimus levels of 8-12 ng/mL for the first 6 months and 5-8 ng/mL thereafter were aimed for in both groups. At 12 months the biopsy-proven rejection rate was 20% in the study group and 32% in the control group (p = 0.09). Patient survival at 1 year was 98% for both groups. Graft survival was 96% for the study group versus 90% for the control group (p = 0.18). Graft function was identical in both groups. Adverse events were similar in both groups apart for more CMV infections in the study group. At the end of the first year 82% of the patients in the study group were steroid-free and 71% continued on tacrolimus monotherapy. These results suggest that alemtuzumab induction together with tacrolimus monotherapy is at least as efficient in renal transplantation as is a tacrolimus-based triple-drug regimen with a similar safety profile but more CMV infections.