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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03386305
Study type Interventional
Source Albert Einstein Healthcare Network
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date December 13, 2017
Completion date December 31, 2021

See also
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Not yet recruiting NCT06304467 - CM for Patients With ALD After Liver Transplant N/A
Active, not recruiting NCT05063071 - Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant Phase 4