Abstract
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 been 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.
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:
a. 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). Registered on 27 May 2020.
Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial