M Shemshadi1, R Hoseini2, R Zareh2, H Otukesh2. 1. Student Research Committee, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran. 2. Pediatric Renal Transplantation and Dialysis Research Center, Iran University of Medical Sciences, Tehran, Iran.
Abstract
BACKGROUND: Several randomized clinical trials performed on adult renal transplant recipients have shown a significant reduction in the incidence of acute rejection by using basiliximab as induction therapy. However, few studies have been conducted on kidney graft survival following the use of the drug among pediatric transplant recipients. OBJECTIVE: To address the efficacy and safety of basiliximab in the improvement of the survival of children with kidney transplants. METHODS: This randomized, double-blind single-center clinical trial was conducted on 28 children (57% male) who underwent live-unrelated renal transplantation. They were randomly assigned into an intervention group receiving basiliximab (10 mg in patients weighing <40 kg or 20 mg in patients ≥40 kg) as induction therapy in combination with the standard immunosuppressive regimen (n=14), or to the control group (n=14) receiving only the standard immunosuppressive regimen (without basiliximab). The outcome was assessed by the measurement of serum creatinine level before transplantation, and 24, 48, and 72 hours as well as 3, 6, and 12 months post-transplantation. The estimated glomerular filtration rate at 12 months post-transplantation and graft survival were also measured. The number of acute rejection episodes in transplant recipients was also considered. RESULTS: The mean±SD age of participants was 12.3±4.2 years. No difference was observed between the two groups in terms of serum creatinine level before and after transplantation at various time points. The mean±SD eGFR at 12 months post-transplantation was 87.8±8.4 in the basiliximab and 85.2±5.8 in the control group (p=0.37). No significant difference was observed between the two groups in terms of acute rejection episodes (25% in basiliximab and 33% in the control group). The graft survival at 1-year post-transplantation was 93% in the basiliximab and 86% in the control group (p=0.54). CONCLUSION: Adding basiliximab to the standard immunosuppressive regimen may not improve the graft survival.
BACKGROUND: Several randomized clinical trials performed on adult renal transplant recipients have shown a significant reduction in the incidence of acute rejection by using basiliximab as induction therapy. However, few studies have been conducted on kidney graft survival following the use of the drug among pediatric transplant recipients. OBJECTIVE: To address the efficacy and safety of basiliximab in the improvement of the survival of children with kidney transplants. METHODS: This randomized, double-blind single-center clinical trial was conducted on 28 children (57% male) who underwent live-unrelated renal transplantation. They were randomly assigned into an intervention group receiving basiliximab (10 mg in patients weighing <40 kg or 20 mg in patients ≥40 kg) as induction therapy in combination with the standard immunosuppressive regimen (n=14), or to the control group (n=14) receiving only the standard immunosuppressive regimen (without basiliximab). The outcome was assessed by the measurement of serum creatinine level before transplantation, and 24, 48, and 72 hours as well as 3, 6, and 12 months post-transplantation. The estimated glomerular filtration rate at 12 months post-transplantation and graft survival were also measured. The number of acute rejection episodes in transplant recipients was also considered. RESULTS: The mean±SD age of participants was 12.3±4.2 years. No difference was observed between the two groups in terms of serum creatinine level before and after transplantation at various time points. The mean±SD eGFR at 12 months post-transplantation was 87.8±8.4 in the basiliximab and 85.2±5.8 in the control group (p=0.37). No significant difference was observed between the two groups in terms of acute rejection episodes (25% in basiliximab and 33% in the control group). The graft survival at 1-year post-transplantation was 93% in the basiliximab and 86% in the control group (p=0.54). CONCLUSION: Adding basiliximab to the standard immunosuppressive regimen may not improve the graft survival.
Entities:
Keywords:
Basiliximab; Immunosuppressive agents; Kidney transplantation; Living donors
Authors: Manuel Pascual; Tom Theruvath; Tatsuo Kawai; Nina Tolkoff-Rubin; A Benedict Cosimi Journal: N Engl J Med Date: 2002-02-21 Impact factor: 91.245
Authors: H Otukesh; M Sharifian; N Simfroosh; A Basiri; R Hoseini; N Sedigh; P Golnari; M Rezai; M Fereshtenejad Journal: Transplant Proc Date: 2005-09 Impact factor: 1.066
Authors: R Grenda; A Watson; K Vondrak; N J A Webb; J Beattie; M Fitzpatrick; M A Saleem; R Trompeter; D V Milford; N E Moghal; D Hughes; F Perner; S Friman; R Van Damme-Lombaerts; F Janssen Journal: Am J Transplant Date: 2006-07 Impact factor: 8.086
Authors: Nahid Rahimzadeh; Hasan Otukesh; Rozita Hoseini; Hadi Sorkhi; Morvarid Otukesh; Sara Hoseini; Mina Torkzaban Journal: Pediatr Transplant Date: 2012-09-04
Authors: Lisa M Willoughby; Mark A Schnitzler; Daniel C Brennan; Brett W Pinsky; Nino Dzebisashvili; Paula M Buchanan; Luca Neri; Lisa A Rocca-Rey; Kevin C Abbott; Krista L Lentine Journal: Transplantation Date: 2009-05-27 Impact factor: 4.939
Authors: Gisela Offner; Burkhard Toenshoff; Britta Höcker; Manuela Krauss; Monika Bulla; Pierre Cochat; Henry Fehrenbach; Wolfgang Fischer; Michel Foulard; Bernd Hoppe; Peter F Hoyer; Therese C Jungraithmayr; Günter Klaus; Kay Latta; Heinz Leichter; Michael J Mihatsch; Joachim Misselwitz; Carmen Montoya; Dirk E Müller-Wiefel; Thomas J Neuhaus; Lars Pape; Uwe Querfeld; Christian Plank; Dieter Schwarke; Simone Wygoda; Lothar B Zimmerhackl Journal: Transplantation Date: 2008-11-15 Impact factor: 4.939