Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant
Status:
Withdrawn
Trial end date:
2022-10-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
The Methodist Hospital Research Institute The Methodist Hospital System