Kidney Transplant ImmunosuppressionNCT06336863
Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
A study testing Allosure and TruGraf and Immunosuppression Taper in people with Kidney Transplant Immunosuppression, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Immunosuppression
- What is being tested?
- Allosure and TruGraf and Immunosuppression Taper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Completion of the parent study (STU-2020-1339)
- Able to provide informed consent
- Absence of donor specific antibodies
- Stable renal function (eGFR>40mL/min for 3 months prior to enrollment)
Who cannot join
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Significant hepatic impairment
- 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
- Proteinuria > 0.5 g/g creatinine on spot urine sample within 3 months of enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: An Extension Protocol for Subjects Previously Enrolled in the "Use of Donor Derived-cell Free DNA (AlloSure) and Gene Expression Profiling (AlloMap Kidney) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients"
The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients."
- Conditions
- Kidney Transplant Immunosuppression
- Being tested
- Allosure and TruGraf, Immunosuppression Taper
- Keywords
- Belatacept Monotherapy, Kidney Transplant Recipients, Immunosuppression, Weaning, DNA Testing, Gene Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allosure and TruGrafDiagnostic test
Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.
Immunosuppression TaperOther
An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent.
| Study group | Role | What they receive |
|---|---|---|
| Immunosuppression Taper | Experimental | 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. Receives: Diagnostic Test: Allosure and TruGraf; Other: Immunosuppression Taper |
| Multi-Drug Regimen | Other | Eligible patients who are not deemed immune quiescent will continue on a multi-drug regimen. Receives: Diagnostic Test: Allosure and TruGraf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney graft rejection
Number of patients with biopsy-proven acute kidney graft rejection
Measured: 12 months after informed consent
Incidence of facilitation to Belatacept monotherapy
Percentage of subjects successfully weaned to a Belatacept monotherapy
Measured: 12 months after the first study visit
Secondary outcomes (5)
Patient Survival after Immunosuppression Wean
Number of patients who died
Measured: 12 months after informed consent
Kidney Graft Failure after Immunosuppression Wean
Number of patients with kidney graft failure. Graft failure is defined as date of patient death or date of re-transplant
Measured: 12 months after informed consent
Mean change in Estimated Glomerular Filtration Rate (eGFR) after 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.
Measured: 12 months after informed consent
Incidence of Proteinuria after Immunosuppression Wean
Proteinuria will be detected by a semiquantitative method of the protein concentration in urine.
Measured: 12 months after informed consent
Incidence 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) in those who have started the immunosuppression wean.
Measured: 12 months after informed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start14 Jun 2024
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant ImmunosuppressionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Wojciechowski, University of Texas Southwestern Medical Center
- Investigators
- David Wojciechowski, DO, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336863
- Sponsor's protocol ID
- STU-2023-1151
- Status last verified
- Jul 2025
- First submitted
- 21 Mar 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Protocol for Subjects Previously Enrolled in the "Use of Donor Derived-cell Free DNA (AlloSure) and Gene Expression Profiling (AlloMap Kidney) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients"
- ClinicalTrials.gov ID
- NCT06336863
- Acronym / sponsor ID
- STU-2023-1151
- Conditions
- Kidney Transplant Immunosuppression
- Keywords
- Belatacept Monotherapy, Kidney Transplant Recipients, Immunosuppression, Weaning, DNA Testing, Gene Expression
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients."
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunosuppression Taper | Experimental | Diagnostic Test: Allosure and TruGraf, Other: Immunosuppression TaperEligible 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. |
| Multi-Drug Regimen | Other | Diagnostic Test: Allosure and TruGrafEligible patients who are not deemed immune quiescent will continue on a multi-drug regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completion of the parent study (STU-2020-1339)
- Able to provide informed consent
- Absence of donor specific antibodies
- Stable renal function (eGFR>40mL/min for 3 months prior to enrollment)
Key exclusion criteria (4 listed)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Significant hepatic impairment
- 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
- Proteinuria > 0.5 g/g creatinine on spot urine sample within 3 months of enrollment
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 |
|---|---|---|
| Allosure and TruGrafPrecision medicine will be employed to withdraw immunosuppression in kidney transplant recipients. | Diagnostic test | Immunosuppression Taper, Multi-Drug Regimen |
| Immunosuppression TaperAn immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent. | Other | Immunosuppression Taper |
Primary outcome
Incidence of acute kidney graft rejection
Time frame: 12 months after informed consent
Number of patients with biopsy-proven acute kidney graft rejection
Incidence of facilitation to Belatacept monotherapy
Time frame: 12 months after the first study visit
Percentage of subjects successfully weaned to a Belatacept monotherapy
5 secondary outcomes
Patient Survival after Immunosuppression Wean
Time frame: 12 months after informed consent
Kidney Graft Failure after Immunosuppression Wean
Time frame: 12 months after informed consent
Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean
Time frame: 12 months after informed consent
Incidence of Proteinuria after Immunosuppression Wean
Time frame: 12 months after informed consent
Incidence of de-novo donor specific antibodies (dnDSA)
Time frame: 12 months after informed consent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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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.
David Wojciechowski, DO 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 study testing Allosure and TruGraf and Immunosuppression Taper 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 14 Jul 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of acute kidney graft rejection (time frame: 12 months after informed consent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2025.