Transitioning kidney transplant patients to Belatacept-only immunosuppression using DNA testing
Use of Donor Derived-cell Free DNA (AlloSure) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients
This study is trying to see if kidney transplant patients can safely switch from taking multiple immunosuppressant drugs to just one called Belatacept, using DNA testing to help guide the process.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04786067 on ClinicalTrials.gov |
What this trial studies
This study aims to identify kidney transplant recipients who can safely transition from multi-drug immunosuppression to Belatacept monotherapy. It utilizes cell-free DNA and gene expression markers to assess immune quiescence, focusing on the effectiveness and safety of Belatacept as a sole immunosuppressant. The primary objective is to evaluate the use of donor-derived cell-free DNA (AlloSure) in facilitating this transition, while secondary objectives include assessing the predictive value of AlloMap and iBox for immune tolerance and adverse outcomes.
Who should consider this trial
Good fit: Ideal candidates include adult kidney transplant recipients with stable renal function who have been on Belatacept for at least three months.
Not a fit: Patients with prior non-kidney organ transplants or those experiencing acute rejection episodes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could simplify immunosuppression regimens for kidney transplant patients, potentially reducing side effects and improving quality of life.
How similar studies have performed: While the approach of using DNA testing for immunosuppression management is innovative, similar studies have shown promise in other contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David Wojciechowski, DO — UT Southwestern Medical Center
- Study coordinator: David Wojciechowski, DO
- Email: David.Wojciechowski@UTSouthwestern.edu
- Phone: 214-645-8300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.