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

M

Methodist Health System

Status

Active, not recruiting

Conditions

Use of Belatacept in Kidney Transplant Patients

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06091995
030.PHA.2022.D

Details and patient eligibility

About

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.

Full 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

Enrollment

300 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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