Liver Transplant
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients undergoing maintenance therapy with Twice-Daily Tacrolimus after liver transplantation.
Detailed description
This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients who have undergone at least one year after liver transplantation and receive maintenance therapy with Twice-Daily Tacrolimus. Enrolled subjects will take TacroBell slow-release cap.(Once-daily Tacrolimus) for 24 weeks and will conduct scheduled tests with four additional visits.
Interventions
DRUGConversion to Once-daily Tacrolimus
* Orally, once-daily in the morning * The first dose is converted to approximately 100% of the existing daily dose, taking into account the subject's blood concentration, after which the investigator check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3\ 10ng/ml.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least one year after liver transplantation * Over 20 years old(male or female) * Patient taking tacrolimus twice daily as a maintenance therapy * Patients with Tacrolimus blood levels of 3-10 at screening * Agreement with written informed consent
Exclusion criteria
* Previously transplanted another organs other than the liver or at the same time * Diagnosed and clinically treated with acute rejection within the last 6 months * Patients who have changed the method of administering concomitant immunosuppressants or steroids within the last month * Diagnosed with cancer in the last five years \[Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer, hepatocellular carcinoma without main vessel invasion or extrahepatic metastasis can be enrolled\] * Patients who have positive HIV test result * Severe systemic infection requiring treatment * At screening * White blood cell count \< 1,500/mm\^3, or platelet \< 50,000/mm\^3, or Serum-C r\> 2.0mg/dl * Liver function test(T-bilirubin, aspartate aminotransferase, alanine aminotransferase)is over 3 times than upper normal limit * Patients Taking HCV(hepatitis C virus) Therapeutic Drugs * Pregnant women or nursing mothers * Fertile women who not practice contraception with appropriate methods * Participated in other trial within 4 weeks * In investigator's judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of composite efficacy failure | until 24 weeks | composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological results of acute rejection | until 24 weeks | acute rejection using Banff 2016 Criteria and RAI(Rejection activity index) score; total 0\ 9 |
| Survival rate of transplanted organ | at 24 weeks | — |
| Incidence of biopsy-confirmed acute rejection | until 24 weeks | episode of biopsy-confirmed acute rejection until 24weeks after conversion |
| Serum-Cr, eGFR(estimated glomerular filtration rate) | at 24 weeks | eGFR using MDRD(Modification of Diet in Renal Disease) method |
| Evaluate safety of TacroBell SR. cap. from number of participants with adverse events | until 24 weeks | — |
| Survival rate of Patients | at 24 weeks | — |
Countries
South Korea
Outcome results
None listed