Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Faisal Specialist Hospital & Research Center
• Treatments: Basiliximab

Criteria

Inclusion Criteria:

• • Male or female ≥ 18 years

• Living donor

• Low immunological risk (defined as):

1. First (primary) transplant

2. ≤ 4 antigen mismatches (HLA matching scheme)

3. Negative HLA Ab screening

Exclusion Criteria:

• • High immunological risk

• HLA identical or zero mismatched transplants

• Receiving cyclosporin as primary maintenance immunosuppressant

• Human immunodeficiency virus (HIV) co-infection

• Pregnant or nursing female

• Has received an investigational medication within the past 30 days

• Has a known contraindication to the administration of Basiliximab

• Suspected or known to have a serious infection

• Multi-organ transplant