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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06091995

Enrollment

Registered

2023-10-23

Start date

2022-08-22

Completion date

2025-07-07

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Use of Belatacept in Kidney Transplant Patients

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

Interventions

BEHAVIORALimpact of administering one dose of belatacept on Estimated Glomerular Filtration Rate(eGFR)

Evaluate the clinical impact of administering one dose of belatacept on eGFR at one-year post-transplant, patient and graft survival outcomes, graft rejection, and incidences of BK virus, EBV and CMV infections.

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
post-transplant outcome	1 year	Patient survival o Graft survival Graft rejection

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORErin Loncharic, PharmD

Methodist Health System

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026