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CompletedNCT06091995Updated Mar 27, 2026

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

An observational study in Use of Belatacept in Kidney Transplant Patients, sponsored by Methodist Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
67
Ages
18 Years to 85 Years
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Use of Belatacept in Kidney Transplant Patients
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In context

Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Age ≥18 years Received living or deceased donor kidney transplant during study period Treatment group: kidney transplant recipients with DGF that received belatacept Control group: kidney transplant recipients with DGF that did not receive belatacept

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
67 participants (actual)
Patient registry
No

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.

    Also known as: impact of administering one dose of belatacept on eGFR

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What researchers measure

Primary outcomes

  1. Time to renal recovery

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

    Time frame: 1 year

  2. post-transplant outcome

    Patient survival o Graft survival Graft rejection

    Time frame: 1 year

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Study locations

1 site
  • Methodist Dallas Medical Center
    Dallas, Texas 75203, United States
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References and documents

Publications

  • 1. Nulojix (belatacept) [package insert]. Princeton, New Jersey: Bristol-Myers Squibb Company; 2014.
  • Vincenti F, Charpentier B, Vanrenterghem Y, Rostaing L, Bresnahan B, Darji P, Massari P, Mondragon-Ramirez GA, Agarwal M, Di Russo G, Lin CS, Garg P, Larsen CP. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant. 2010 Mar;10(3):535-46. doi: 10.1111/j.1600-6143.2009.03005.x. PubMed 20415897 ↗
  • Durrbach A, Pestana JM, Pearson T, Vincenti F, Garcia VD, Campistol J, Rial Mdel C, Florman S, Block A, Di Russo G, Xing J, Garg P, Grinyo J. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant. 2010 Mar;10(3):547-57. doi: 10.1111/j.1600-6143.2010.03016.x. PubMed 20415898 ↗
  • Jorgenson MR, Descourouez JL, Brady BL, Bowman L, Hammad S, Kaiser TE, Laub MR, Melaragno JI, Park JM, Chandran MM. Alternatives to immediate release tacrolimus in solid organ transplant recipients: When the gold standard is in short supply. Clin Transplant. 2020 Jul;34(7):e13903. doi: 10.1111/ctr.13903. Epub 2020 May 29. PubMed 32400907 ↗
  • de Graav GN, Baan CC, Clahsen-van Groningen MC, Kraaijeveld R, Dieterich M, Verschoor W, von der Thusen JH, Roelen DL, Cadogan M, van de Wetering J, van Rosmalen J, Weimar W, Hesselink DA. A Randomized Controlled Clinical Trial Comparing Belatacept With Tacrolimus After De Novo Kidney Transplantation. Transplantation. 2017 Oct;101(10):2571-2581. doi: 10.1097/TP.0000000000001755. PubMed 28403127 ↗

Individual participant data

Plan to share: Yes — The PI is committed to disseminate research results in a timely fashion. Sharing of data generated by this project will be carried out through presentation at national scientific meetings and/or publication in open access journals. The PI will also make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Supporting information: Study protocol, Sap, Csr, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06091995
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Aug 22, 2022
Primary completion
Jul 7, 2025
Completion
Jul 7, 2025
Last update
Mar 27, 2026

Study contacts

Erin Loncharic, PharmD
principal investigator · Methodist Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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