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OpenTrials
Completed

NCT Number: NCT06091995

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

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.

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Key information

Conditions

Use of Belatacept in Kidney Transplant Patients

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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.

Other names: impact of administering one dose of belatacept on eGFR

Primary outcomes

  1. Time to renal recovery

    Time frame: 1 year

    weeks 1-4, and months 3, 6, 9 and 12) to capture potential short- and long-term effects on renal function.

  2. post-transplant outcome

    Time frame: 1 year

    Patient survival

    o Graft survival Graft rejection

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.