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NCT Number: NCT03386305

Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EnvarsusXR

Drug

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

Other names: Immunosuppression

Tacrolimus

Drug

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

Other names: Standard of Care

Primary outcomes

  1. Change in Medication Adherence

    Time frame: From baseline to 6 months

    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.

Secondary outcomes

  1. Change in Quality of life

    Time frame: From baseline to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Albert Einstein Healthcare Network

Other

Collaborators

  • Veloxis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2017
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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