Clinical trial NCT04786067: Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
Official title: Use of Donor Derived-cell Free DNA (AlloSure) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Kidney Transplant Immunosuppression
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: CareDx
First posted: 2021-03-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Number of patients with acute kidney graft rejection
timeFrame: 12 months after the date of the first immunosuppression taper
Secondary outcomes:
measure: Number of patients who died
timeFrame: 12 months after the start of immunosuppression wean, up to 36 months
measure: Number of patients with kidney graft failure
timeFrame: 12 months after the start of immunosuppression wean
measure: Mean change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline, 12 months after the start of immunosuppression wean
measure: Number of participants with Proteinuria
timeFrame: 12 months after the start of immunosuppression wean
measure: Number of participants with appearance of de-novo donor specific antibodies (dnDSA)
timeFrame: 12 months after the start of immunosuppression wean
measure: Negative predictable value as measured by AlloMap®
timeFrame: 12 months after the start of immunosuppression wean
measure: Mean prediction score of allograft loss as measured by iBox
timeFrame: 12 months after the start of immunosuppression wean
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: David Wojciechowski, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern Medical Center
name: Cyrus Feizpour, MD
role: PRINCIPAL_INVESTIGATOR
References: