At a glance
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A Phase IV, Single Center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of the Conversion to Tacrolimus Modified Release, ADVAGRAF® After 12 Month Treatment With a Tacrolimus Stably in Liver Transplant Recipients.
In Brief
A Phase 4 clinical trial evaluating Advagraf for Evidence of Liver Transplantation. Completed, enrolled 101 participants across 1 site.
Detailed Summary
The primary objective of this study is to evaluate the efficacy of 6-month treatment with Advagraf® converted from 12-month treatment with tacrolimus in stable liver transplant recipients. The secondary objective of this study is to evaluate severity of acute rejection confirmed by biopsy in 24 weeks, incidence of chronic rejection, patient and graft survival rates in 24 weeks, incidence of adverse events, blood pressure, tacrolimus trough level, drug compliance, and adherence.
Study Details
Timeline
Interventions
Researchers must check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5\~10ng/ml of study treatment. Duration of treatment The investigational product will be administered for 24 weeks. (The lowest blood levels shall be adjusted at the discretion of the researchers, taking a blood sample is carried out in the morning before administrated of Investigational Product) Tacrolimus blood level is 3-10 ng/ml for 6 months prior to screening and during the maintenance therapy. ( ① -1day to enrollment : swich to the day before ADVAGRAF®, ② 0day to enrollment : the day swich to ADVAGRAF® ) Duration of treatment the investigational product will be administered for 24 weeks.