Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant

In spite of conventional immunosuppression with lymphocyte-depleting induction followed by tacrolimus- and mycophenolate-based regimens, African American (AA) renal transplant recipients experience higher rates of acute rejection (AR), donor specific antibodies (DSA), and graft failure. Envarsus Extended-Release (XR)® (ENV) is a novel extended-release formulation of tacrolimus with a favorable pharmacokinetic profile, even in the setting of CYP3A5\*1 allele (rapid metabolizers). The investigator will evaluate the safety and efficacy of early dose escalation with ENV in AA recipients. The study hypothesis is that higher tacrolimus target concentrations may be achieved without typical dose-limiting toxicities, and this may ultimately result in lower incidence of early AR, DSA, and graft loss.

NCT Number	NCT04665310
Lead Sponsor	The Methodist Hospital Research Institute Collaborators: Veloxis Pharmaceuticals
Conditions	Kidney Disease, End-Stage, Donor Specific Antibodies, Acute Rejection of Renal Transplant
Enrollment	46 participants
Start Date	2018-09-01
Primary Completion	2025-07-31 (estimated)
Study Completion	2025-10-31 (estimated)
Updated on ClinicalTrials.gov	2025-03-14