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* To determine the utility of novel blood-based immune monitoring tools (Allosure and Trugraf) to facilitate belatacept monotherapy. * To determine the percent of belatacept-treated renal transplant patients that can be safely converted to belatacept monotherapy.
This study will examine whether renal transplant recipients treated with a belatacept-based immunosuppressive regimen can safely be weaned off all non-belatacept immunosuppression (mycophenolate, mTORi, prednisone) in a stepwise fashion. To this end, participants will undergo monthly "immune monitoring" using the Allosure (dd-cfDNA) and Trugraf (RNA profiling) blood tests to determine if they are in a state of immune quiescence. Only patients who are deemed to be immune quiescent, will continue to be weaned of non-belatacept immunosuppression.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Massachusetts General Hospital
Boston, Massachusetts, United States
Start Date
February 11, 2020
Primary Completion Date
September 30, 2021
Completion Date
June 1, 2023
Last Updated
December 4, 2023
17
ACTUAL participants
Allosure
DIAGNOSTIC_TEST
Immunosuppression reduction
DRUG
Trugraf
DIAGNOSTIC_TEST
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT07006532
NCT06694740
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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