{"title":"Use of Basiliximab with the Standard Immunosuppressive Protocol in Pediatric Renal Transplantation: A Double-Blind Randomized Clinical Trial.","authors":"M Shemshadi, R Hoseini, R Zareh, H Otukesh","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To address the efficacy and safety of basiliximab in the improvement of the survival of children with kidney transplants.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>Adding basiliximab to the standard immunosuppressive regimen may not improve the graft survival.</p>","PeriodicalId":14242,"journal":{"name":"International Journal of Organ Transplantation Medicine","volume":"11 1","pages":"8-14"},"PeriodicalIF":0.3000,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724772/pdf/ijotm-11-008.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Organ Transplantation Medicine","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"TRANSPLANTATION","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍：
The International Journal of Organ Transplantation Medicine (IJOTM) is a quarterly peer-reviewed English-language journal that publishes high-quality basic sciences and clinical research on transplantation. The scope of the journal includes organ and tissue donation, procurement and preservation; surgical techniques, innovations, and novelties in all aspects of transplantation; genomics and immunobiology; immunosuppressive drugs and pharmacology relevant to transplantation; graft survival and prevention of graft dysfunction and failure; clinical trials and population analyses in the field of transplantation; transplant complications; cell and tissue transplantation; infection; post-transplant malignancies; sociological and ethical issues and xenotransplantation.
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