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

Description

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

Conditions

Kidney Transplant Immunosuppression

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Kidney Transplant Immunosuppression
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

David Wojciechowski, DO, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Cyrus Feizpour, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

2026-03-30