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

NCT04665310 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-03-14

No results posted yet for this study

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.

Conditions

  • Kidney Disease, End-Stage
  • Donor Specific Antibodies
  • Acute Rejection of Renal Transplant

Interventions

DRUG

Envarsus XR

tacrolimus, extended-release tablets, a calcineurin inhibitor

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    collaborator INDUSTRY

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Ahmed O Gaber, MD · Houston Methodist Physicians Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2025-07-31
Completion
2025-10-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04665310 on ClinicalTrials.gov