Abstract
BackgroundInduction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not been fully investigated.AimsTo compare different induction therapeutic strategies with 2 doses of basiliximab vs. no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol.MethodsProspective, randomized, double blind, non-inferiority, controlled clinical trialExpected outcomes1. Primary outcomes:Biopsy-proven acute rejection within first year following transplant2. Secondary outcomes:a. Patient and graft survival at 1 yearb. eGFR at 6 months and at 12 monthsc. Emergence of de novo donor-specific antibodies (DSAs)Trial registrationThe study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.
Highlights
The standard immunosuppression protocols for solid organ transplantation have evolved to permit reliable short-term graft survival, such that transplantation has become the preferred therapy for end-stage organ failure
Clinical trials leading to the US FDA drug approval were mainly coupled with cyclosporin as main maintenance immunosuppressant drug
The use of basiliximab induction when combined with tacrolimus-based immunosuppression has not been thoroughly investigated in well-structured, randomized clinical trials [18]
Summary
Prospective, randomized, double blind, non-inferiority, controlled clinical trial. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2. Patient and graft survival at 1 year b. EGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs). Trial registration: The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127).
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