CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 17 enrolled
Drug / intervention
Immunosuppression reduction +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04177095
NCT04177095Phase 4Completed
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Immune Monitoring to Facilitate Belatacept Monotherapy

Massachusetts General Hospital·interventional·Posted Nov 26, 2019·Updated Dec 4, 2023

In Brief

A Phase 4 clinical trial evaluating Allosure, Immunosuppression reduction, and 1 other intervention for Kidney Transplant Rejection and Immunosuppression. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplant Rejection, Immunosuppression
CountriesUnited States
CollaboratorsTransplant Genomics, Inc., CareDx

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedNov 26, 2019
Enrollment StartFeb 11, 2020
Primary CompletionSep 30, 2021
Study CompletionJun 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.6 years ago

Interventions

Allosureother

Monthly monitoring of dd-cfDNA levels in blood

Immunosuppression reductiondrug

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

Trugrafother

Monthly monitoring of Trugraf result