Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This investigator-initiated post-marketing study will evaluate the role of Hispanic ethnicity on drug dosing of Envarsus in first-time stable renal transplant recipients. Tacrolimus trough drug levels will be studied as a primary endpoint at 24 hours after drug dosing and at steady state (e.g., trough level at 3 months post conversion) and secondary compliance assessments will be done by pill counts at clinic visits. Secondary outcomes will be the safety of once a day dosing as well as assessment of graft rejection and graft failure. In addition, concentration/dose ratios will be analyzed. The results of this study will provide important information about dosing of once a day tacrolimus (Envarsus) in Hispanic kidney transplant patients, which represents the largest growing group of patients with End-Stage Renal Disease

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Institute of Renal Research
• Collaborators: Balboa Institute of Transplantation; University of California, San Diego
• Treatments: Immunosuppressive Agents; Tacrolimus

Criteria

Inclusion Criteria:

• Male or Female 18 years of age or older.

• The subject is a first time stable renal transplant patients, who have received their transplant at least 3 months before study entry.

• The subject is willing to commit to the study design.

• The subject is considered to have stable allograft function defined as no documented rejection episodes within one month of screening.

• The subject is not currently receiving treatment with other experimental therapies directed at their transplant.

Exclusion Criteria:

• The subject has undergone a prior organ or bone marrow transplant.

• The subject has taken any interacting/contraindicated drug determined by the Investigator within 30 days of administration of the protocol.

• Any study drug allergies and if there are high serum donor specific antibody levels (DSA) or a high panel reactive antibody level (PRA).

• Documented treatment of rejection within 30 days of onset of the screening visit.