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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
David Wojciechowski, DO
David.Wojciechowski@UTSouthwestern.edu
214-645-8300
Time Frame
Start Date: 2021-07-28
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 25
Treatments
Experimental: Immunosuppression Taper
Patients included in this arm are kidney transplant recipients with stable kidney function currently on or are converting to a Belatacept based immunosuppression regimen. Eligible patients who are deemed immune quiescent after a 3 month monitoring period will undergo sequential withdrawal of immunosuppression medications over a 12 month period from a three drug regimen to a Belatacept only immunosuppression regimen. During the total 15 month period patients will be monitored with monthly clinic visits, blood draws for routine monitoring as well as donor derived cell free DNA and genetic testing through KidneyCare to monitor immune suppression.
Related Therapeutic Areas
Sponsors
Collaborators: CareDx
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov