Clinical trial NCT03386305: Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant
Official title: A Randomized Controlled Trial to Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Post Liver Transplant
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
Collaborators: name: Veloxis Pharmaceuticals
First posted: 2017-12-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Medication Adherence
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Change in Quality of life
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Einstein Healthcare Network
name: Manisha Verma, MBBS, MPH
role: STUDY_DIRECTOR
References: