COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2021-07-28

Study Completion:2025-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04786067

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

David Wojciechowski, DO

PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Cyrus Feizpour, MD

PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

David Wojciechowski, DO, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center
Cyrus Feizpour, MD, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-28

Study Completion Date2025-07-30

Study Record Updates

Study Start Date2021-07-28

Study Completion Date2025-07-30

Terms related to this study

Additional Relevant MeSH Terms

Kidney Transplant Immunosuppression