Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

Post Liver Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03386305
• Other study ID #: 5024
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: December 13, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Liver Transplant

Intervention

Drug:
• EnvarsusXR
Patients randomized to study drug will be converted to EnvarsusXR once daily.
• Tacrolimus
Patients continue to take Tacrolimus BID, as a part of routine care.

Locations

Country	Name	City	State
United States	Einstein Medical Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network	Veloxis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to 6 months
Secondary	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.	From baseline to 6 months