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Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression | Clinical Trials | Clareo Health

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Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

Use of Donor Derived-cell Free DNA (AlloSure) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients

NCT04786067•University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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 as markers of immune quiescence. The primary objective will be to determine if donor derived-cell free DNA (AlloSure) can be utilized to facilitate Belatacept monotherapy, and to determine if Belatacept is safe and effective as immunosuppression in kidney transplant recipients. The secondary objective is to determine the utility of AlloMap as a predictor of immune quiescence and tolerance of immunosuppressive de-escalation to Belatacept monotherapy, and to evaluate the performance of iBox in predicting adverse outcomes in patients transitioned to Belatacept monotherapy

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States

Key Dates

Start Date

July 28, 2021

Primary Completion Date

July 10, 2025

Completion Date

July 30, 2025

Last Updated

January 12, 2026

Enrollment

ACTUAL participants

Conditions

Kidney Transplant Immunosuppression

Interventions

Belatacept

DRUG