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

Phase 4

Recruiting

• Conditions: Kidney Transplantation
• Interventions: Drug: Basiliximab 20 milligram [Simulect]; Other: Normal Saline

• Registration Number: NCT04404127
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Study Start: 2020-09-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18
• Primary Completion: 2023-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Induction with basiliximab	Basiliximab 20 milligram [Simulect]	-
No induction Arm	Normal Saline	-

Primary Outcome Measures

Name	Time	Method
Rate of biopsy proven acute rejection within first year following transplant	1 year after transplant

Secondary Outcome Measures

Name	Time	Method
Rate of graft survival at 1 year	1 year after transplant
Rate of emergence of de novo donor specific antibodies (DSAs)	1 year after transplant
Rate of decline in eGFR at 6 months and at 12 months	1 year after transplant

Trial Locations

Locations (1)

King Faisal Specialist Hospital and Research Centre (KFSHRC); 🇸🇦 Riyadh, Saudi Arabia