Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients with Delayed Graft Function

Active, not recruiting

• Conditions: Use of Belatacept in Kidney Transplant Patients

• Registration Number: NCT06091995
• Lead Sponsor: Methodist Health System

Brief Summary

Evaluate the impact of one dose of belatacept in patients with Delayed Graft Function(DGF) on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus(BKV), Epstein-Barr Virus(EBV) and/or cytomegalovirus (CMV) infections.

Detailed Description

Evaluate the impact of one dose of belatacept in patients with DGF on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus, EBV and/or cytomegalovirus (CMV) infections.

At Methodist Dallas Medical Center(MDMC), while providers may choose to initiate belatacept to delay tacrolimus initiation, the impact of this practice on time to renal recovery has not been evaluated. The purpose of this study is to determine if administering belatacept to delay initiation of tacrolimus shortens time to renal recovery in DGF patients

Study Timeline

• Study Start: 2022-08-22
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-08-22
• Study Completion: 2025-08-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age ≥18 years
• Received living or deceased donor kidney transplant during study period
• Documented DGF

Exclusion Criteria

• Multiple organ transplant
• Recipients with acute rejection present on first biopsy evaluation before first belatacept dose
• Recipients with a first dose of belatacept after index discharge or tacrolimus initiation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
post-transplant outcome	1 year	Patient survival; o Graft survival Graft rejection
Time to renal recovery	1 year	weeks 1-4, and months 3, 6, 9 and 12) to capture potential short- and long-term effects on renal function.

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States