Kidney Transplantation Clinical Trial
Official title:
Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial
Background: Induction 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 fully investigated Aims: To compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol (Appendix 2) Methods: Prospective, randomized, double blind, non-inferiority, controlled clinical trial Expected Outcomes: 1. Primary outcomes: Biopsy proven acute rejection within first year following transplant 2. Secondary outcomes: 1. Patient and graft survival at 1 year 2. Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months 3. Emergence of de novo donor specific antibodies (DSAs)
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