Use of Basiliximab with the Standard Immunosuppressive Protocol in Pediatric Renal Transplantation: A Double-Blind Randomized Clinical Trial.Shemshadi, M., et al.
International Journal of Organ Transplantation Medicine 2020; 11(1): 8-14.
The aim of this study was to investigate whether the addition of basiliximab to the standard immunosuppressive regimen led to improvement in survival of paediatric kidney transplant patients.
Patients were randomised into two groups: the intervention group, in which patients received basiliximab combined with standard immunosuppressive regimen; or the control group, where patients received the standard immunosuppressive regimen alone.
28 paediatric renal transplant recipients.
The primary outcome was the assessment of serum creatinine before and after transplantation. The secondary outcome was the occurrence of acute rejection episodes.
This is a small study in paediatric renal transplantation including 28 patients. The study adequately randomised patients using a permuted block system. There are some concerns about sources of bias and the conduct of the study. The study is described as blinded but does not explain how this was done. All patients had living, unrelated transplantation, which seems unusual for a paediatric population. The primary outcome was serum creatinine, measured at several time points after transplantation up to 12 months, and there was no significant difference between the groups. Rejection was diagnosed by a rise in creatinine with a response to steroids. It was not necessary to biopsy the graft unless the renal function continued to deteriorate, and this may have influenced the results. The authors include a table of studies that have made similar comparisons, but several published studies are missing from here. The conclusion of the study is that Basiliximab does not reduce acute rejection when added to the immune suppression regimen, compared to standard therapy. However, the study is clearly underpowered for this outcome and there may also be a problem with the way this outcome was defined. A detailed discussion of the study limitations is not presented in the paper.