Immune Monitoring to Facilitate Belatacept Monotherapy

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: CareDx; Transplant Genomics, Inc.
• Treatments: Abatacept; Everolimus; Mycophenolic Acid; Prednisone; Sirolimus

Criteria

Inclusion Criteria:

• Age minimum 18 years

• Written informed consent

• Single kidney transplant recipient (i.e. no combined organ transplants)

• Treated with de novo belatacept since transplantation (i.e. no previous use of calcineurin inhibitor or mTOR inhibitor for the current transplant)

• At least 1 year after transplantation or after initiation of belatacept

• Stable renal function (eGFR > 40 ml/min continuously during previous 6 months)

• Blood biomarkers indicate immune quiescence (for Allosure this corresponds to dd-cfDNA < 1%; for Trugraf this corresponds to "TX" signature)

• No history of BK viremia in current allograft

Exclusion Criteria:

• History of biopsy-proven acute rejection

• Presence of donor-specific antibodies (at any MFI)

• Spot urine protein/creatinine ratio > 0.5 g/g