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Clinical trial

Immune Monitoring to Facilitate Belatacept Monotherapy

ID
Name
2019P002608
Description
* 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.
Trial arms
Trial start
2020-02-11
Estimated PCD
2021-09-30
Trial end
2023-06-01
Status
Completed
Phase
Early phase I
Treatment
Allosure
Monthly monitoring of dd-cfDNA levels in blood
Arms:
Belatacept treated patients
Other names:
donor-derived cell-free DNA (dd-cfDNA)
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
Arms:
Belatacept treated patients
Other names:
Belatacept, mycophenolate, sirolimus, everolimus, prednisone
Trugraf
Monthly monitoring of Trugraf result
Arms:
Belatacept treated patients
Size
17
Primary endpoint
Incidence of Acute Rejection
Enrollment through 12 months
Incidence of Acute Rejection
Through study completion, 1 year
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective single-center, single-arm pilot study', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 17, 'type': 'ACTUAL'}}
Updated at
2023-12-04

1 organization

1 product

2 indications

Organization
Massachusetts General Hospital
Product
Immunosuppression reduction
Indication
Kidney Transplant Rejection
Indication
Immune suppression