Immunological Tolerance in Patients With Mismatched Kidney Transplants

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

July 7, 2023

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2026

Conditions
End Stage Kidney DiseaseImmunological ToleranceKidney Transplant Failure and RejectionChronic Kidney Diseases
Interventions
COMBINATION_PRODUCT

Donor CD34+, CD3+. and belumosudil

"Immediately after living donor kidney transplantation, subjects will begin a conditioning regimen of rATG and total lymphoid irradiation. An infusion of at least 8 X106 donor CD34 cells/kg recipient weight and of at least 10 X106 donor CD3 cells/kg recipient weight will then be given. A triple immunosuppressive regimen of tacrolimus, corticosteroids, and mycophenolate will be utilized.~Corticosteroids will be given on a tapering schedule from day 0 through the first four months. Tacrolimus will be given on a tapering schedule from day 1 through month 18. Mycophenolate will be given at a fixed dose from day 11 through month 12.~Subjects will receive belumosudil 200 mg by mouth daily from day 28 following the kidney transplant through month 24."

Trial Locations (1)

90095

University of California, Los Angeles, Los Angeles

All Listed Sponsors
lead

University of California, Los Angeles

OTHER