Status:
COMPLETED
Twice-daily Tacrolimus and Everolimus Convert to Once-daily Tacrolimus and Everolimus in Liver Transplant Recipient
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
It has been identified that nonadherence to immunosuppressant regimen may cause long-term graft failure and death in solid organ transplant recipients. Therefore, simplification of the immunosuppressi...
Detailed Description
Randomized trial of everolimus (EVR) with reduced tacrolimus (TAC) regimen after liver transplantation has shown similar incidence of composite efficacy failure rate to a standard tacrolimus regimen, ...
Eligibility Criteria
Inclusion
- Key inclusion criteria
- Stable liver transplant recipients are eligible for inclusion in this study and have to fulfill all of the following criteria:
- Liver Transplant Recipients have received liver transplantations for at least 6+1 months prior to enrollment
- Liver Transplant Recipients have no acute rejection episodes within 3 months prior to the enrollment and are clinically stable
- Liver Transplant Recipients have been treated with twice-daily regimen of tacrolimus(TAC) plus everolimus(EVR) and TAC and EVR trough levels have stayed within targeted ranges for at least 6 weeks prior to enrollment
- Provide written informed consent prior to inclusion.
- Liver transplant recipients who are 18-65 years of age of a primary liver transplant
- Allograft functioning at an acceptable level as defined by the AST, ALT, Total Bilirubin levels ≤3 times ULN prior to enrollment.
- Abbreviated MDRD eGFR ≥ 30 mL/min/1.73m2. Key exclusion criteria
- Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- Patients who are recipients of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant. Patients who have a combined liver-kidney transplant.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Existence of any surgical, medical or mental conditions, other than the current transplantation, which, in the opinion of the investigator, might interfere with the objectives of the study.
- Pregnant or nursing (lactating) women.
Exclusion
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03256864
Start Date
January 1 2016
End Date
May 30 2020
Last Update
June 5 2020
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taoyuan District, Taiwan