Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 1/12/2019 |
| Start Date: | December 13, 2017 |
| End Date: | December 13, 2019 |
| Contact: | Manisha Verma, MBBS, MPH |
| Email: | VermaM@einstein.edu |
| Phone: | 215456 1026 |
A Randomized Controlled Trial to 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.
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.
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).
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).
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
We found this trial at
1
site
Philadelphia, Pennsylvania 19141
Principal Investigator: Radi Zaki, MD
Phone: 215-456-1026
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