Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)

Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Conversion to TacroBell SR Cap.(Once-Daily Tacrolimus) in Patients Undergoing Maintenance Therapy With Twice-Daily Tacrolimus After Liver Transplantation.

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.

Study Overview

• Status: Unknown
• Conditions: Liver Transplant
• Intervention / Treatment: Drug: Conversion to Once-daily Tacrolimus

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.

• Study Type: Interventional
• Enrollment (Anticipated): 146
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Conversion to Once-daily Tacrolimus; Conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) at least one year after liver transplantation

Drug: Conversion 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.; Other Names: TacroBell slow-release cap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of composite efficacy failure	composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure	until 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of biopsy-confirmed acute rejection	episode of biopsy-confirmed acute rejection until 24weeks after conversion	until 24 weeks
Pathological results of acute rejection	acute rejection using Banff 2016 Criteria and RAI(Rejection activity index) score; total 0~9	until 24 weeks
Survival rate of transplanted organ		at 24 weeks
Survival rate of Patients		at 24 weeks
Serum-Cr, eGFR(estimated glomerular filtration rate)	eGFR using MDRD(Modification of Diet in Renal Disease) method	at 24 weeks
Evaluate safety of TacroBell SR. cap. from number of participants with adverse events		until 24 weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Anticipated): February 22, 2021
• Study Completion (Anticipated): April 8, 2021

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: B93_03LT1901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No