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Immune Monitoring to Facilitate Belatacept Monotherapy

NCT04177095 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-12-04

Study results available
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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.

Conditions

  • Kidney Transplant Rejection
  • Immunosuppression

Interventions

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

Sponsors & Collaborators

  • Transplant Genomics, Inc.

    collaborator INDUSTRY

  • CareDx

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Hannah Gilligan, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-11
Primary Completion
2021-09-30
Completion
2023-06-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04177095 on ClinicalTrials.gov