Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

Phase 3Active Not RecruitingNCT03386305

Albert Einstein Healthcare Network35 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Post Liver Transplant

Interventions

EnvarsusXRDRUG

Patients randomized to study drug will be converted to EnvarsusXR once daily.

TacrolimusDRUG

Patients continue to take Tacrolimus BID, as a part of routine care.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are 1 year post liver transplant, but within 5 years of transplant * Serum Creatinine\<= 2.5 mg/dl; AST,ALT, AP and GGT\<=2 times ULN * Patient must be on a stable tacrolimus dose, with tacrolimus trough levels between 5-12 ng/ml for 4 or more weeks before enrolment Exclusion Criteria: * Cognitive impairment which precludes participation * Projected survival, in the opinion of the provider, of less than three months * Any other solid organ transplant (kidney or pancreas) * Use of any drug which is known to interfere with tacrolimus metabolism

Locations (1)

Einstein Medical Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Change in Medication Adherence

Self reported using BAASIS instrument. BAASIS measures taking, skipping and dose reduction of drugs, with a recall period of 4 weeks. It consists of 4 questions with a 6 point response scale (ranging from never to every day). An additional overall adherence is ranked on a scale of 0 to 100 using a visual analog scale.

Time frame: From baseline to 6 months

Secondary Outcomes

Change in Quality of life

Self reported, using PROMIS-29. PROMIS is a result of the NIH support to develop a "psychometrically validated, dynamic system to measure QOL and patient reported outcomes in study participants. PROMIS-29 comprises a set of 29 questions evaluating seven QOL domains: Physical function, anxiety, depression, fatigue, sleep disturbance, social function and pain. The scores are reported as a T score (mean 50, SD=10) centered on the sample representative of 2000 US general census considering demographic variables.

Time frame: From baseline to 6 months

Data from ClinicalTrials.gov

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