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Enrolling by Invitation

NCT Number: NCT06336863

Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

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."

Enrolling by Invitation

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Key information

Conditions

Kidney Transplant Immunosuppression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Allosure and TruGraf

Diagnostic Test

Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.

Immunosuppression Taper

Other

An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent.

Primary outcomes

  1. Incidence of acute kidney graft rejection

    Time frame: 12 months after informed consent

    Number of patients with biopsy-proven acute kidney graft rejection

  2. Incidence of facilitation to Belatacept monotherapy

    Time frame: 12 months after the first study visit

    Percentage of subjects successfully weaned to a Belatacept monotherapy

Secondary outcomes

  1. Patient Survival after Immunosuppression Wean

    Time frame: 12 months after informed consent

    Number of patients who died

  2. Kidney Graft Failure after Immunosuppression Wean

    Time frame: 12 months after informed consent

    Number of patients with kidney graft failure. Graft failure is defined as date of patient death or date of re-transplant

  3. Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean

    Time frame: 12 months after informed consent

    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.

  4. Incidence of Proteinuria after Immunosuppression Wean

    Time frame: 12 months after informed consent

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

  5. Incidence of de-novo donor specific antibodies (dnDSA)

    Time frame: 12 months after informed consent

    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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study 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"

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 29, 2024
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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