Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients with Delayed Graft Function
NCT ID: NCT06091995
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
300 participants
OBSERVATIONAL
2022-08-22
2025-08-22
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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impact 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received living or deceased donor kidney transplant during study period
* Documented DGF
Exclusion Criteria
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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Methodist Health System
OTHER
Responsible Party
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Principal Investigators
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Erin Loncharic, PharmD
Role: PRINCIPAL_INVESTIGATOR
Methodist Health System
Locations
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Methodist Dallas Medical Center
Dallas, Texas, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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030.PHA.2022.D
Identifier Type: -
Identifier Source: org_study_id
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