Immune Monitoring to Facilitate Belatacept Monotherapy

NCT04177095 | Completed Phase 4 Results DMC FDA Drug FDA Device

• 1 other identifier: 2019P002608
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Rejection; Immunosuppression

Outcome Measures

Primary Outcomes (2)

• Incidence of Acute Rejection

  Biopsy-proven according to Banff 2017 criteria

  Enrollment through 12 months

• Incidence of Acute Rejection

  Biopsy-proven according to Banff 2017 criteria

  Through study completion, 1 year

Secondary Outcomes (4)

• Increase in eGFR

  From baseline to 12 months

• Rate of New-onset Proteinuria

  At 12 months

• Incidence of de Novo Donor Specific Antibodies

  At 12 months

• Survival

  At 12 months

Study Arms (1)

Belatacept treated patients

EXPERIMENTAL

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

Diagnostic Test: Allosure; Drug: Immunosuppression reduction; Diagnostic Test: Trugraf

Interventions

Allosure DIAGNOSTIC_TEST

Monthly monitoring of dd-cfDNA levels in blood

Also known as: donor-derived cell-free DNA (dd-cfDNA)

Belatacept treated patients

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

Also known as: Belatacept, mycophenolate, sirolimus, everolimus, prednisone

Belatacept treated patients

Trugraf DIAGNOSTIC_TEST

Monthly monitoring of Trugraf result

Belatacept treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of biopsy-proven acute rejection
• Presence of donor-specific antibodies (at any MFI)
• Spot urine protein/creatinine ratio \> 0.5 g/g

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Transplant Genomics, Inc.: collaborator
• CareDx: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Abatacept; Mycophenolic Acid; Sirolimus; Everolimus; Prednisone

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Macrolides; Lactones; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Hannah Gilligan, MD
• Organization: Massachusetts General Hospital

hgilligan@mgh.harvard.edu

617-726-2000

Study Officials

• Hannah Gilligan, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective single-center, single-arm pilot study

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: February 11, 2020
• Primary Completion: September 30, 2021
• Study Completion: June 1, 2023
• Last Updated: December 4, 2023
• Results First Posted: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)