NCT03386305

Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

A Randomized Controlled Trial to Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Albert Einstein Healthcare Network · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the medication adherence, clinical efficacy, and safety of EnvarsusXR in stable post liver transplant patient using a Phase III randomized controlled study. The primary outcome is change in medication adherence from baseline to the end of the study, assessed using a validated instrument (BAASIS- Basel Assessment of Adherence with Immunosuppressive medication Scales) and standard deviation of Tacrolimus levels.

Detailed description

The main aim of this study is to assess the immunosuppressant adherence, efficacy, and safety in post liver transplant patients converted from twice daily tacro to once daily EnvarsusXR. Tacrolimus trough level, clinical markers of liver disease, HbA1c , eGFR will be assessed at baseline, 1 week, 2 week, 4 week, 3 month and 6 months. Graft rejection will be assessed using routine standard guidelines to identify the cause. All patients post 1 year liver transplant, and within 5 years will be eligible to participate. The primary hypothesis is that once daily dosing will improve medication adherence in patients randomized to the test arm as compared to the control arm, over a period of 9 months. The clinical efficacy will be assessed by no difference in standard deviation of tacrolimus in the two groups. The secondary hypothesis is that improved medication adherence will lead to improved patient reported quality of life (as assessed by PROMIS-29), and better health outcomes (as assessed by HbA1c, eGFR).

Conditions

• Post Liver Transplant

Interventions

Type	Name	Description
DRUG	EnvarsusXR	Patients randomized to study drug will be converted to EnvarsusXR once daily.
DRUG	Tacrolimus	Patients continue to take Tacrolimus BID, as a part of routine care.

Timeline

• Start date: 2017-12-13
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2017-12-29
• Last updated: 2021-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study