Immune Monitoring to Facilitate Belatacept Monotherapy

Status Completed

Clinical Trial Summary

- 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04177095
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	February 11, 2020
Completion date	June 1, 2023

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