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Immune Monitoring to Facilitate Belatacept Monotherapy

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04177095
Collaborator
Transplant Genomics, Inc. (Industry), CareDx (Industry)
20
Enrollment
1
Location
1
Arm
34.6
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Allosure
  • Drug: Immunosuppression reduction
  • Diagnostic Test: Trugraf
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective single-center, single-arm pilot studyProspective single-center, single-arm pilot study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Immune Monitoring to Facilitate Belatacept Monotherapy
Actual Study Start Date :
Feb 11, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Belatacept treated patients

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

Diagnostic Test: Allosure
Monthly monitoring of dd-cfDNA levels in blood
Other Names:
  • donor-derived cell-free DNA (dd-cfDNA)

    • 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
    Other Names:
  • Belatacept
  • mycophenolate
  • sirolimus
  • everolimus
  • prednisone

    • Diagnostic Test: Trugraf
    Monthly monitoring of Trugraf result

    Outcome Measures

    Primary Outcome Measures

    1. Rate of acute rejection [24 months]

      Biopsy-proven according to Banff 2017 criteria

    Secondary Outcome Measures

    1. Change in eGFR [24 months]

      Calculated using CKD-EPI formula

    2. Rate of new-onset proteinuria [24 months]

      Defined as g/g creatinine, measured on random urine sample

    3. Rate of de novo donor specific antibodies [24 months]

      Screened for using Luminex platform

    4. Survival [24 months]

      Overall and death-censored graft survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Transplant Genomics, Inc.
    • CareDx

    Investigators

    • Principal Investigator: Hannah Gilligan, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hannah Gilligan, Principal investigator, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04177095
    Other Study ID Numbers:
    • 2019P002608
    First Posted:
    Nov 26, 2019
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Sirolimus
    Prednisone
    Everolimus

    Study Results

    No Results Posted as of Sep 5, 2021