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

NCT04069065 | Unknown Phase 4

• 1 other identifier: B93_03LT1901
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant

Outcome Measures

Primary Outcomes (1)

• Incidence of composite efficacy failure

  composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure

  until 24 weeks

Secondary Outcomes (6)

• Incidence of biopsy-confirmed acute rejection

  until 24 weeks

• Pathological results of acute rejection

  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)

  at 24 weeks

Study Arms (1)

Conversion to Once-daily Tacrolimus

EXPERIMENTAL

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

Drug: Conversion to Once-daily Tacrolimus

Interventions

Conversion to Once-daily Tacrolimus DRUG

* 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.

Also known as: TacroBell slow-release cap.

Conversion to Once-daily Tacrolimus

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: July 31, 2019
• Primary Completion: February 22, 2021
• Study Completion: April 8, 2021
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

KR (1)