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Completed

NCT Number: NCT04786067

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

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

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Key information

Conditions

Kidney Transplant Immunosuppression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UT 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

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Belatacept

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of patients who died

    Time frame: 12 months after the start of immunosuppression wean, up to 36 months

    Incidence of death will be measured from 12 months after the start of immunosuppresion wean, up to 36 months

  2. Number of patients with kidney graft failure

    Time frame: 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

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

    Time frame: 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.

  4. Number of participants with Proteinuria

    Time frame: 12 months after the start of immunosuppression wean

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

  5. Number of participants with appearance of de-novo donor specific antibodies (dnDSA)

    Time frame: 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)

  6. Negative predictable value as measured by AlloMap®

    Time frame: 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 - 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.

  7. Mean prediction score of allograft loss as measured by iBox

    Time frame: 12 months after the start of immunosuppression wean

    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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • CareDx

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2021
Registry last updated
Jan 12, 2026

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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