Trial Outcomes & Findings for Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression (NCT NCT04786067)

Last Updated: 2026-08-14

Results Overview

Number of patients with Acute kidney graft rejection confirmed by biopsy by 2017 Banff Criteria. Incidence of biopsy proven acute kidney graft rejection at 12 months after the start of immunosuppression taper

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

12 months after the date of the first immunosuppression taper

Results posted on

2026-08-14

Participant Flow

25 kidney transplant recipients whose maintenance immunosuppression regimen included Belatacept were recruited from an outpatient clinic. Patients were identified through medical record review to determine eligibility based upon inclusion and exclusion criteria. An investigator called eligible patients to discuss interest in participation and written, informed consent was obtained at a routine outpatient visit for those agreeable.

Eligible patients were enrolled in the study for a 3-month lead-in period to demonstrate stability and establish baseline molecular diagnostic markers. During this initial observation period, immune quiescence was assessed using the following criteria: stable renal function (eGFR no more than 20% below the value at inclusion), AlloSure ≤1%, AlloMap \< 11.5, absence of proteinuria (UPCR \<0.5 g/g), and no evidence of de novo DSA or biopsy-proven acute rejection.

Participant milestones

Participant milestones
Measure	Experimental: Immunosuppression Taper Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.	3-Month Lead-In Eligible patients were enrolled in the study for a 3-month lead-in period to demonstrate stability and establish baseline molecular diagnostic markers.
Observational Lead-In STARTED	0	0	25
Observational Lead-In COMPLETED	0	0	24
Observational Lead-In NOT COMPLETED	0	0	1
Study Treatment STARTED	12	12	0
Study Treatment COMPLETED	12	12	0
Study Treatment NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Immunosuppression Taper Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.	3-Month Lead-In Eligible patients were enrolled in the study for a 3-month lead-in period to demonstrate stability and establish baseline molecular diagnostic markers.
Observational Lead-In Physician Decision	0	0	1

Baseline Characteristics

2 subjects were excluded from data analysis due to developments of proteinuria and de-novo donor-specific antibodies (DSA) during the lead-in period.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3-Month Lead-In n=23 Participants Eligible patients were enrolled in the study for a 3-month lead-in period to demonstrate stability and establish baseline molecular diagnostic markers.
Age, Categorical <=18 years	0 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo donor-specific antibodies (DSA) during the lead-in period.
Age, Categorical Between 18 and 65 years	15 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo donor-specific antibodies (DSA) during the lead-in period.
Age, Categorical >=65 years	8 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo donor-specific antibodies (DSA) during the lead-in period.
Sex: Female, Male Female	8 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Sex: Female, Male Male	15 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Race (NIH/OMB) Asian	3 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Race (NIH/OMB) Black or African American	7 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Race (NIH/OMB) White	12 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Race (NIH/OMB) More than one race	0 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Etiology Diabetes	10 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Etiology Hypertension	5 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Etiology Glomerulonephritis	1 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Etiology Other	7 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Type of Transplant Living Donor	3 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Type of Transplant Donation after Brain Death (DBD) Donor	14 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Type of Transplant Donation after Circulatory Death (DCD) Donor	6 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Human Leukocyte Antigen (HLA) Mismatch 0 HLA Mismatch	1 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Human Leukocyte Antigen (HLA) Mismatch 1 HLA Mismatch	0 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Human Leukocyte Antigen (HLA) Mismatch 2 HLA Mismatch	0 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Human Leukocyte Antigen (HLA) Mismatch 3 HLA Mismatch	2 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Human Leukocyte Antigen (HLA) Mismatch 4 HLA Mismatch	4 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Human Leukocyte Antigen (HLA) Mismatch 5 HLA Mismatch	12 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Human Leukocyte Antigen (HLA) Mismatch 6 HLA Mismatch	4 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Immunosuppression Therapy Belatacept + Mycophenolate	2 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Immunosuppression Therapy Belatacept + Prednisone	2 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Immunosuppression Therapy Belatacept + Sirolimus	1 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Immunosuppression Therapy Belatacept + Mycophenolate + Prednisone	15 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.
Immunosuppression Therapy Belatacept + Everolimus + Prednisone	3 Participants n=11 Participants • 2 subjects were excluded from data analysis due to developments of proteinuria and de-novo DSA during the lead-in period.

PRIMARY outcome

Timeframe: 12 months after the date of the first immunosuppression taper

Population: 24 subjects entered the study treatment period from the observational lead-in period. Out of the 12 subjects under the observational arm, 1 subject was excluded from data analysis due to development of de-novo DSA during the lead-in period.

Outcome measures

Outcome measures
Measure	Experimental: Immunosuppression Taper n=12 Participants Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational n=11 Participants Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.
Number of Patients With Acute Kidney Graft Rejection	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months after the start of immunosuppression wean

Incidence of death will be measured from 12 months after the start of immunosuppresion wean.

Outcome measures

Outcome measures
Measure	Experimental: Immunosuppression Taper n=12 Participants Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational n=11 Participants Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.
Number of Patients Who Died	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months after the start of immunosuppression wean

Incidence of kidney graft failure will be measured from the start of immunosuppresion wean until 12 months after. Graft failure is defined as date of patient death or date of retransplant

Outcome measures

Outcome measures
Measure	Experimental: Immunosuppression Taper n=12 Participants Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational n=11 Participants Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.
Number of Patients With Kidney Graft Failure	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 12 months after the start of immunosuppression wean

Estimated glomerular filtration rate (eGFR) in blood will be measured at the beginning of enrollment and the difference will be measured to the end of the study as a measure of change in kidney function.

Outcome measures

Outcome measures
Measure	Experimental: Immunosuppression Taper n=12 Participants Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational n=11 Participants Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.
Mean Change in Estimated Glomerular Filtration Rate (eGFR)	7.17 mL/min/1.72m2 Standard Deviation 11.04	-9.58 mL/min/1.72m2 Standard Deviation 8.07

SECONDARY outcome

Timeframe: 12 months after the start of immunosuppression weaning

Proteinuria will be detected by a semiquantitative method of the protein concentration in urine.

Outcome measures

Outcome measures
Measure	Experimental: Immunosuppression Taper n=12 Participants Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational n=11 Participants Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.
Number of Participants With Proteinuria	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months after the start of immunosuppression wean

HLA type I and type II in blood will be used to detect the presence of de-novo donor specific antibodies (dnDSA)

Outcome measures

Outcome measures
Measure	Experimental: Immunosuppression Taper n=12 Participants Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational n=11 Participants Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.
Number of Participants With Appearance of De-novo Donor Specific Antibodies (dnDSA)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months after the start of immunosuppression wean

Negative predictable value measured by AlloMap®, expressed as a percent, that the patient is not experiencing rejection at the time of testing. AlloMap® is a panel of 20 gene assays, 11 informative and 9 used for normalization and/or quality control, which produces gene expression data used in the calculation of an AlloMap Test score is an integer ranging from 0 to 40. Compared with patients in the same post- transplant period, the lower the score, the lower the probability of acute cellular rejection at the time of testing.

Outcome measures

Outcome measures
Measure	Experimental: Immunosuppression Taper n=12 Participants Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational n=11 Participants Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.
AlloMap® Level	9.85 Score on a scale Standard Deviation 1.82	11.71 Score on a scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: 12 months after the start of immunosuppression wean

Population: This outcome measure was originally included, but iBox measures were not obtained during the conduct of the study. As a result, no participant-level or summary data are available to report in the Outcome Measure data table. This outcome measure was not assessed, and no analyses were performed. Because the study has been completed, this data will not be collected in the future.

iBox is the validated tool for predicting the risk of kidney transplant loss based on artificial intelligence. Range of score is 0%-100%, higher score indicates better kidney survival.

Outcome measures

Outcome measures
Measure	Experimental: Immunosuppression Taper Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.
Mean Prediction Score of Allograft Loss as Measured by iBox	0 Participants	0 Participants

Adverse Events

Experimental: Immunosuppression Taper

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Observational

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

3-Month Lead-In

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: Immunosuppression Taper n=12 participants at risk Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational n=12 participants at risk Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.	3-Month Lead-In n=25 participants at risk Eligible patients were enrolled in the study for a 3-month lead-in period to demonstrate stability and establish baseline molecular diagnostic markers.
General disorders Acute/Subacute Right Thalamic Infarct	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/12 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
General disorders E. coli bacteremia	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
General disorders Fever	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/12 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
General disorders Uncontrolled Hypertension	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
Blood and lymphatic system disorders Occluded ulnar artery	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
General disorders Cryptococcal pneumonia	0.00% 0/12 • From enrollment until end of study (Month 12).	0.00% 0/12 • From enrollment until end of study (Month 12).	4.0% 1/25 • Number of events 1 • From enrollment until end of study (Month 12).
General disorders Diabetic ketoacidosis	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
General disorders Psoas muscle hematoma	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
General disorders Phalanx osteomyelitis	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
Ear and labyrinth disorders Otitis media	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
Renal and urinary disorders UTI	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).

Other adverse events

Other adverse events
Measure	Experimental: Immunosuppression Taper n=12 participants at risk Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.	Observational n=12 participants at risk Eligible patients who are not deemed immune quiescent will continue with surveillance on a multi-drug regimen.	3-Month Lead-In n=25 participants at risk Eligible patients were enrolled in the study for a 3-month lead-in period to demonstrate stability and establish baseline molecular diagnostic markers.
General disorders Elevated AlloSure	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/12 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
Renal and urinary disorders AKI	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
General disorders Multinodular goiter	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
General disorders Leg pain	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
Infections and infestations COVID-19	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
Renal and urinary disorders UTI	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
Musculoskeletal and connective tissue disorders Left distal fibular fracture	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/12 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
Skin and subcutaneous tissue disorders Pressure blister	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/12 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
Infections and infestations Rhinovirus/enterovirus	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/12 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma In Situ	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/12 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
General disorders Thrush	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
General disorders Flu-like symptoms	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).
General disorders Post-transplant Diabetes Mellitus	0.00% 0/12 • From enrollment until end of study (Month 12).	8.3% 1/12 • Number of events 1 • From enrollment until end of study (Month 12).	0.00% 0/25 • From enrollment until end of study (Month 12).

Additional Information

David Wojciechowski

University of Texas Southwestern Medical Center

Phone: 214-645-7846

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigator or other appropriate Institution authors will provide Sponsor a full and complete text copy for review at least thirty (30) calendar days prior to the submission to a third party for review, its publication, or other disclosure. Authors will consider any Sponsor comments in good faith but are under no obligation to incorporate any Sponsor suggestions.
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