Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

Albert Einstein Healthcare Network

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Post Liver Transplant

Treatments: Drug: Tacrolimus; Drug: EnvarsusXR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03386305

5024

Details and patient eligibility

About

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.

Full 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).

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

EnvarsusXR arm

Experimental group

Description:

Patients are converted to once daily EnvarsusXR (study drug). The patients continue taking this medication for 9 months of the study. Initial dosage will be 0.8 times the total daily dose of tacro bid, due to higher bioavailability. All subsequent dose adjustments will be based on maintenance of target tacro trough levels within range of 5-12 ng/ml.

Treatment:

Drug: EnvarsusXR

Standard of care arm

Active Comparator group

Description:

Post Liver Transplant patients take Tacrolimus twice daily as a part of standard of care. Those participating in the study will continue to take tacrolimus twice daily, as apart of their regular care. As a part of the study, they will complete the medication adherence and quality of life instruments.

Treatment:

Drug: Tacrolimus