NCT04404127

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

Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Basiliximab 20 milligram [Simulect]	Basiliximab
OTHER	Normal Saline	No-Induction

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-05-01
• Completion: 2025-05-01
• First posted: 2020-05-27
• Last updated: 2021-02-18

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated drug study