Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients
Status:
Recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
Summary
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)