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OpenTrials
Completed

NCT Number: NCT04177095

Immune Monitoring to Facilitate Belatacept Monotherapy

* 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.

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Key information

Conditions

Kidney Transplant Rejection Immunosuppression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allosure

Diagnostic Test

Monthly monitoring of dd-cfDNA levels in blood

Other names: donor-derived cell-free DNA (dd-cfDNA)

Immunosuppression reduction

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

Other names: Belatacept, mycophenolate, sirolimus, everolimus, prednisone

Trugraf

Diagnostic Test

Monthly monitoring of Trugraf result

Primary outcomes

  1. Incidence of Acute Rejection

    Time frame: Enrollment through 12 months

    Biopsy-proven according to Banff 2017 criteria

  2. Incidence of Acute Rejection

    Time frame: Through study completion, 1 year

    Biopsy-proven according to Banff 2017 criteria

Secondary outcomes

  1. Increase in eGFR

    Time frame: From baseline to 12 months

    Calculated using CKD-EPI formula

  2. Rate of New-onset Proteinuria

    Time frame: At 12 months

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

  3. Incidence of de Novo Donor Specific Antibodies

    Time frame: At 12 months

    Screened for using Luminex platform

  4. Survival

    Time frame: At 12 months

    Overall and death-censored graft survival

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • CareDx
  • Transplant Genomics, Inc.

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Nov 26, 2019
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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