Official Title
Immune Monitoring to Facilitate Belatacept Monotherapy
Brief Title
Immune Monitoring to Facilitate Belatacept Monotherapy
Protocol ID
NCT04177095
Lead Sponsor
Massachusetts General Hospital
Brief 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.
Study Period
-
Enrollment Count
17 participants
Eligibility 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
Filters
Kidney Transplant Rejection
Immunosuppression
PHASE4
COMPLETED
ADULT
OLDER_ADULT