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

  • STATUS
    Recruiting
  • End date
    May 25, 2025
  • participants needed
    140
  • sponsor
    King Faisal Specialist Hospital & Research Center
Updated on 25 February 2021

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)

Details
Condition Organ Transplantation, Renal transplant, Organ Transplant - Pediatric, Organ Transplant, Kidney Transplantation, kidney transplant, renal transplantation, kidney transplants
Treatment Normal saline, Basiliximab 20 milligram [Simulect]
Clinical Study IdentifierNCT04404127
SponsorKing Faisal Specialist Hospital & Research Center
Last Modified on25 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female 18 years
Living donor
Low immunological risk (defined as)
First (primary) transplant
4 antigen mismatches (HLA matching scheme)
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
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