Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant
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|ClinicalTrials.gov Identifier: NCT03386305|
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post Liver Transplant||Drug: EnvarsusXR Drug: Tacrolimus||Phase 2 Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 13, 2019|
|Estimated Study Completion Date :||December 13, 2019|
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.
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.
Patients continue to take Tacrolimus BID, as a part of routine care.
Other Name: Standard of Care
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03386305
|Contact: Manisha Verma, MBBS, MPH||215456 1026||VermaM@einstein.edu|
|United States, Pennsylvania|
|Einstein Medical Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19141|
|Contact: Manisha Verma 215-456-1026 email@example.com|
|Principal Investigator: Radi Zaki, MD|
|Sub-Investigator: Manisha Verma, MBBS,MPH|
|Study Director:||Manisha Verma, MBBS, MPH||Einstein Healthcare Network|