Kidney Transplant ImmunosuppressionPhase 4NCT04786067

Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

A Phase 4 study testing Belatacept in people with Kidney Transplant Immunosuppression, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Transplant Immunosuppression
What is being tested?: Belatacept
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 28 Jul 2021to 30 Jul 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult (>18 years) recipients of a kidney-only transplant, including re-transplants
Non-HLA identical Living or Deceased Donor Grafts
Able to provide informed consent
Absence of donor specific antigens
Stable renal function (eGFR>40mL/min for 3 months prior to enrollment)
Patients treated with Belatacept as part of de novo immunosuppression or converted to Belatacept with stable kidney function for 3 months (as stated above)
Patients who underwent kidney transplantation at least 9 months prior to study entry

Who cannot join

Prior or concurrent non-kidney organ transplants
Presence of BK nephropathy in current graft
Recipient on any other investigational drug in the 12 weeks prior to inclusion
Patient with history of recent (<3mo), recurrent, or severe (Banff Grade 2 or greater or unable to be treated with steroids) acute rejection episodes
Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
Significant hepatic impairment
Bilateral kidney transplantation
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Trial locations and contacts

1 site in 1 country.

United States1 site

UT Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

Official title: Use of Donor Derived-cell Free DNA (AlloSure) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients

The purpose of the study is to identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression as markers of immune quiescence. The primary objective will be to determine if donor derived-cell free DNA (AlloSure) can be utilized to facilitate Belatacept monotherapy, and to determine if Belatacept is safe and effective as immunosuppression in kidney transplant recipients. The secondary objective is to determine the utility of AlloMap as a predictor of immune quiescence and tolerance of immunosuppressive de-escalation to Belatacept monotherapy, and to evaluate the performance of iBox in predicting adverse outcomes in patients transitioned to Belatacept monotherapy

Conditions: Kidney Transplant Immunosuppression
Being tested: Belatacept

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BelataceptDrug
Patients will have tapering of their multi-drug immunosuppression, until Belatacept is the sole medication in their immunosuppression regimen. Belatacept will be administered as an infusion, as is routinely done clinically.

Study groups in NCT04786067
Study group	Role	What they receive
Immunosuppression Taper	Experimental	Patients included in this arm are kidney transplant recipients with stable kidney function currently on or are converting to a Belatacept based immunosuppression regimen. Eligible patients who are deemed immune quiescent after a 3 month monitoring period will undergo sequential withdrawal of immunosuppression medications over a 12 month period from a three drug regimen to a Belatacept only immunosuppression regimen. During the total 15 month period patients will be monitored with monthly clinic visits, blood draws for routine monitoring as well as donor derived cell free DNA and genetic testing through KidneyCare to monitor immune suppression. Receives: Drug: Belatacept

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Acute Kidney Graft Rejection
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
Measured: 12 months after the date of the first immunosuppression taper

Secondary outcomes (7)

Number of Patients Who Died
Incidence of death will be measured from 12 months after the start of immunosuppresion wean.
Measured: 12 months after the start of immunosuppression wean
Number of Patients With Kidney Graft Failure
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
Measured: 12 months after the start of immunosuppression wean
Mean Change in Estimated Glomerular Filtration Rate (eGFR)
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.
Measured: Baseline, 12 months after the start of immunosuppression wean
Number of Participants With Proteinuria
Proteinuria will be detected by a semiquantitative method of the protein concentration in urine.
Measured: 12 months after the start of immunosuppression weaning
Number of Participants With Appearance of De-novo Donor Specific Antibodies (dnDSA)
HLA type I and type II in blood will be used to detect the presence of de-novo donor specific antibodies (dnDSA)
Measured: 12 months after the start of immunosuppression wean
AlloMap® Level
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.
Measured: 12 months after the start of immunosuppression wean
Mean Prediction Score of Allograft Loss as Measured by iBox
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.
Measured: 12 months after the start of immunosuppression wean

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202130 Jul 2025

First posted8 Mar 2021
Study start28 Jul 2021
Primary completion10 Jul 2025
Study completion30 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kidney Transplant ImmunosuppressionStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04786067
Sponsor's protocol ID: STU-2020-1339
Other IDs: CTA202012-0033
Status last verified: Feb 2025
First submitted: 23 Feb 2021
Last updated: 14 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
Active, not recruitingPhase 4
Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs
Immunosuppression
RecruitingPhase 2
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
Renal Transplant Failure and Rejection

All Kidney Transplant Immunosuppression trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Donor Derived-cell Free DNA (AlloSure) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients
ClinicalTrials.gov ID: NCT04786067
Acronym / sponsor ID: STU-2020-1339
Conditions: Kidney Transplant Immunosuppression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: CareDx
Study start: 28 Jul 2021 (actual)
Primary completion: 10 Jul 2025 (actual)
Study completion: 30 Jul 2025 (actual)
First posted: 8 Mar 2021 (actual)
Results: Posted 14 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Immunosuppression Taper	Experimental	Drug: BelataceptPatients included in this arm are kidney transplant recipients with stable kidney function currently on or are converting to a Belatacept based immunosuppression regimen. Eligible patients who are deemed immune quiescent after a 3 month monitoring period will undergo sequential withdrawal of immunosuppression medications over a 12 month period from a three drug regimen to a Belatacept only immunosuppression regimen. During the total 15 month period patients will be monitored with monthly clinic visits, blood draws for routine monitoring as well as donor derived cell free DNA and genetic testing through KidneyCare to monitor immune suppression.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Adult (>18 years) recipients of a kidney-only transplant, including re-transplants
Non-HLA identical Living or Deceased Donor Grafts
Able to provide informed consent
Absence of donor specific antigens
Stable renal function (eGFR>40mL/min for 3 months prior to enrollment)

Key exclusion criteria (8 listed)

Prior or concurrent non-kidney organ transplants
Presence of BK nephropathy in current graft
Recipient on any other investigational drug in the 12 weeks prior to inclusion
Patient with history of recent (<3mo), recurrent, or severe (Banff Grade 2 or greater or unable to be treated with steroids) acute rejection episodes
Female participant who is pregnant, lactating or planning pregnancy during the course of the trial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BelataceptPatients will have tapering of their multi-drug immunosuppression, until Belatacept is the sole medication in their immunosuppression regimen. Belatacept will be administered as an infusion, as is routinely done clinically.	Drug	Immunosuppression Taper

Primary outcome

Number of Patients With Acute Kidney Graft Rejection
Time frame: 12 months after the date of the first immunosuppression taper
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

7 secondary outcomes

Number of Patients Who Died
Time frame: 12 months after the start of immunosuppression wean
Number of Patients With Kidney Graft Failure
Time frame: 12 months after the start of immunosuppression wean
Mean Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, 12 months after the start of immunosuppression wean
Number of Participants With Proteinuria
Time frame: 12 months after the start of immunosuppression weaning
Number of Participants With Appearance of De-novo Donor Specific Antibodies (dnDSA)
Time frame: 12 months after the start of immunosuppression wean
AlloMap® Level
Time frame: 12 months after the start of immunosuppression wean
Mean Prediction Score of Allograft Loss as Measured by iBox
Time frame: 12 months after the start of immunosuppression wean

Results and safety

Results posted to the registry on 14 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Immunosuppression Taper	0	0
Observational	0	0
3-Month Lead-In	25	24

Primary outcome: Number of Patients With Acute Kidney Graft Rejection

Time frame: 12 months after the date of the first immunosuppression taper. Count of participants. Unit: Participants

Measure	Experimental: Immunosuppression Taper n = 12	Observational n = 11
Value	0	0

Population analysed: 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.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of study (Month 12).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: Immunosuppression Taper	2 of 12 (16.7%)	5 of 12 (41.7%)	0 of 12
Observational	4 of 12 (33.3%)	6 of 12 (50%)	0 of 12
3-Month Lead-In	1 of 25 (4%)	0 of 25 (0%)	0 of 25

Limitations and caveats (from the sponsor): This was a small study in low-risk patients that needs confirmation in a larger cohort before the use of molecular diagnostics can be routinely recommended to guide immunosuppression minimization in clinical practice. Additionally, we utilized a conservative, frequent immune monitoring strategy. As more data regarding the safety and efficacy of minimization in these patients becomes available, studies comparing different monitoring strategies may be warranted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Kidney Transplant Immunosuppression

Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
Active, not recruitingPhase 4
Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs
Immunosuppression
RecruitingPhase 2
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Wojciechowski, DO principal investigator

University of Texas Southwestern Medical Center

Cyrus Feizpour, MD principal investigator

University of Texas Southwestern Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Belatacept in people with Kidney Transplant Immunosuppression, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Acute Kidney Graft Rejection (time frame: 12 months after the date of the first immunosuppression taper). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04786067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.