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Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03386305
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : January 7, 2020
Veloxis Pharmaceuticals
Information provided by (Responsible Party):
Radi Zaki, Albert Einstein Healthcare Network

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.

Condition or disease Intervention/treatment Phase
Post Liver Transplant Drug: EnvarsusXR Drug: Tacrolimus Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial to Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: EnvarsusXR arm
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.
Drug: EnvarsusXR
Patients randomized to study drug will be converted to EnvarsusXR once daily.
Other Name: Immunosuppression

Active Comparator: Standard of care arm
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.
Drug: Tacrolimus
Patients continue to take Tacrolimus BID, as a part of routine care.
Other Name: Standard of Care

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03386305

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Contact: Manisha Verma, MBBS, MPH 215456 1026

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United States, Pennsylvania
Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Manisha Verma    215-456-1026   
Principal Investigator: Radi Zaki, MD         
Sub-Investigator: Manisha Verma, MBBS,MPH         
Sponsors and Collaborators
Albert Einstein Healthcare Network
Veloxis Pharmaceuticals
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Study Director: Manisha Verma, MBBS, MPH Einstein Healthcare Network
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Responsible Party: Radi Zaki, Co-Chair, Transplantation, Albert Einstein Healthcare Network Identifier: NCT03386305    
Other Study ID Numbers: 5024
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action