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Immune Monitoring to Facilitate Belatacept Monotherapy

NCT ID: NCT04177095

Last Updated: 2023-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-11

Study Completion Date

2023-06-01

Brief Summary

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* 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

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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.

Conditions

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Kidney Transplant Rejection Immunosuppression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective single-center, single-arm pilot study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Belatacept treated patients

Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone

Group Type EXPERIMENTAL

Allosure

Intervention Type DIAGNOSTIC_TEST

Monthly monitoring of dd-cfDNA levels in blood

Immunosuppression reduction

Intervention Type DRUG

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

Trugraf

Intervention Type DIAGNOSTIC_TEST

Monthly monitoring of Trugraf result

Interventions

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Allosure

Monthly monitoring of dd-cfDNA levels in blood

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DRUG

Trugraf

Monthly monitoring of Trugraf result

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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donor-derived cell-free DNA (dd-cfDNA) Belatacept mycophenolate sirolimus everolimus prednisone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Transplant Genomics, Inc.

INDUSTRY

Sponsor Role collaborator

CareDx

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hannah Gilligan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hannah Gilligan, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2019P002608

Identifier Type: -

Identifier Source: org_study_id