Status:
RECRUITING
Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
CareDx
Conditions:
Kidney Transplant Immunosuppression
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression...
Eligibility Criteria
Inclusion
- Adult (\>18 years) recipients of a kidney-only transplant, including re-transplants
- Non-HLA identical Living or Deceased Donor Grafts
- Able to provide informed consent
- Absence of donor specific antigens
- Stable renal function (eGFR\>40mL/min for 3 months prior to enrollment)
- Patients treated with Belatacept as part of de novo immunosuppression or converted to Belatacept with stable kidney function for 3 months (as stated above)
- Patients who underwent kidney transplantation at least 9 months prior to study entry
Exclusion
- Prior or concurrent non-kidney organ transplants
- Presence of BK nephropathy in current graft
- Recipient on any other investigational drug in the 12 weeks prior to inclusion
- Patient with history of recent (\<3mo), recurrent, or severe (Banff Grade 2 or greater or unable to be treated with steroids) acute rejection episodes
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Significant hepatic impairment
- Bilateral kidney transplantation
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Key Trial Info
Start Date :
July 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04786067
Start Date
July 28 2021
End Date
March 30 2026
Last Update
March 6 2025
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390