Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)
- Conditions
- Liver Transplant
- Interventions
- Drug: Conversion to Once-daily Tacrolimus
- Registration Number
- NCT04069065
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 146
- 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
-
Previously transplanted another organs other than the liver or at the same time
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Diagnosed and clinically treated with acute rejection within the last 6 months
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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]
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Patients who have positive HIV test result
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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
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Fertile women who not practice contraception with appropriate methods
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Participated in other trial within 4 weeks
-
In investigator's judgment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Conversion to Once-daily Tacrolimus Conversion to Once-daily Tacrolimus Conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) at least one year after liver transplantation
- Primary Outcome Measures
Name Time Method Incidence of composite efficacy failure until 24 weeks composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
- Secondary Outcome Measures
Name Time Method Pathological results of acute rejection until 24 weeks acute rejection using Banff 2016 Criteria and RAI(Rejection activity index) score; total 0\~9
Evaluate safety of TacroBell SR. cap. from number of participants with adverse events until 24 weeks Incidence of biopsy-confirmed acute rejection until 24 weeks episode of biopsy-confirmed acute rejection until 24weeks after conversion
Survival rate of transplanted organ at 24 weeks Survival rate of Patients at 24 weeks Serum-Cr, eGFR(estimated glomerular filtration rate) at 24 weeks eGFR using MDRD(Modification of Diet in Renal Disease) method
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of