Trial Outcomes & Findings for Immune Monitoring to Facilitate Belatacept Monotherapy (NCT NCT04177095)

Results Overview

Biopsy-proven according to Banff 2017 criteria

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

Enrollment through 12 months

Results posted on

2023-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Belatacept Treated Patients Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood 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 Trugraf: Monthly monitoring of Trugraf result
Overall Study STARTED	17
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Belatacept Treated Patients Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood 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 Trugraf: Monthly monitoring of Trugraf result
Overall Study Withdrawal by Subject	3
Overall Study Screen Failure	3
Overall Study Problems with the Trugraf assay	1

Baseline Characteristics

Immune Monitoring to Facilitate Belatacept Monotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belatacept Treated Patients n=17 Participants Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood 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 Trugraf: Monthly monitoring of Trugraf result
Age, Customized 18 years or older	17 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment through 12 months

Biopsy-proven according to Banff 2017 criteria

Outcome measures

Outcome measures
Measure	Belatacept Treated Patients n=12 Participants Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood 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 Trugraf: Monthly monitoring of Trugraf result
Incidence of Acute Rejection	0 Participants

PRIMARY outcome

Timeframe: Through study completion, 1 year

Biopsy-proven according to Banff 2017 criteria

Outcome measures

Outcome measures
Measure	Belatacept Treated Patients n=12 Participants Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood 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 Trugraf: Monthly monitoring of Trugraf result
Incidence of Acute Rejection	0 Participants

SECONDARY outcome

Timeframe: From baseline to 12 months

Calculated using CKD-EPI formula

Outcome measures

Outcome measures
Measure	Belatacept Treated Patients n=12 Participants Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood 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 Trugraf: Monthly monitoring of Trugraf result
Increase in eGFR	6 Participants

SECONDARY outcome

Timeframe: At 12 months

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

Outcome measures

Outcome measures
Measure	Belatacept Treated Patients n=12 Participants Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood 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 Trugraf: Monthly monitoring of Trugraf result
Rate of New-onset Proteinuria	1 Participants

SECONDARY outcome

Timeframe: At 12 months

Screened for using Luminex platform

Outcome measures

Outcome measures
Measure	Belatacept Treated Patients n=12 Participants Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood 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 Trugraf: Monthly monitoring of Trugraf result
Incidence of de Novo Donor Specific Antibodies	0 Participants

SECONDARY outcome

Timeframe: At 12 months

Overall and death-censored graft survival

Outcome measures

Outcome measures
Measure	Belatacept Treated Patients n=12 Participants Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood 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 Trugraf: Monthly monitoring of Trugraf result
Survival	12 Participants

Adverse Events

Belatacept Treated Patients

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Belatacept Treated Patients n=12 participants at risk Renal transplant recipients treated with a combination of belatacept and any of the following: mycophenolate, sirolimus, everolimus and prednisone Allosure: Monthly monitoring of dd-cfDNA levels in blood 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 Trugraf: Monthly monitoring of Trugraf result
Infections and infestations Urinary Tract Infection	8.3% 1/12 • Number of events 2 • 2 Years
Investigations Elevated LFTs	8.3% 1/12 • Number of events 1 • 2 Years
Investigations Fatigue	8.3% 1/12 • Number of events 1 • 2 Years
Renal and urinary disorders Proteinuria	8.3% 1/12 • Number of events 1 • 2 Years
Investigations Elevated Creatinine	16.7% 2/12 • Number of events 2 • 2 Years
Musculoskeletal and connective tissue disorders Knee Pain	8.3% 1/12 • Number of events 1 • 2 Years

Additional Information

Hannah Gilligan, MD

Massachusetts General Hospital

Phone: 617-726-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place