NCT04177095

Immune Monitoring to Facilitate Belatacept Monotherapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Kidney Transplant Rejection
• Immunosuppression

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Allosure	Monthly monitoring of dd-cfDNA levels in blood
DRUG	Immunosuppression reduction	Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of Allosure and Trugraf results
DIAGNOSTIC_TEST	Trugraf	Monthly monitoring of Trugraf result

Timeline

• Start date: 2020-02-11
• Primary completion: 2021-09-30
• Completion: 2023-06-01
• First posted: 2019-11-26
• Last updated: 2023-12-04
• Results posted: 2023-12-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study