Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients

NCT ID: NCT03749356

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-05
• Study Completion Date: 2020-12-04

Brief Summary

The purpose of this study is to evaluate the efficacy and safety and of Once-Daily Tacrolimus (TacroBell SR Cap.) in patients who received renal transplantation.

Detailed Description

This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of combined Once-Daily Tacrolimus (TacroBell SR Cap.) administration for 24 weeks in patients with immunosuppressive therapies after renal transplantation.

Conditions

Kidney Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Once-Daily Tacrolimus

One arm: TacroBell SR Cap.

Group Type: EXPERIMENTAL

TacroBell SR cap.

Intervention Type: DRUG

• Orally, once-daily in the morning
• After first dose 0.2mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~12ng/ml for 0 to 3months and then at 3~8ng/ml for 3 to 6months of study treatment.

Interventions

TacroBell SR cap.

• Orally, once-daily in the morning
• After first dose 0.2mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~12ng/ml for 0 to 3months and then at 3~8ng/ml for 3 to 6months of study treatment.

Intervention Type: DRUG

Other Intervention Names

Tacrolimus SR cap.

Eligibility Criteria

Inclusion Criteria

• Over 20 years old(male or female)
• Patients who are planning to receive a kidney from a deceased or a living non-related/related donor
• Agreement with written informed consent

Exclusion Criteria

• Previously received organs other than kidneys or who are planed to be transplanted simultaneously
• Receive a kidney from a donor whose ABO blood type is not compatible with that of the recipient
• Receive a kidney from a related donor who showed HLA-0 mismatch (identical)
• Undergo desensitization therapy with high sensitization
• Diagnosed with cancer in the last five years [Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer can be enrolled.]
• Patients or donors who have positive HIV test result
• Inadequate for registration under the judgment of the investigator due to severe gastrointestinal disorders
• Severe systemic infection requiring treatment
• Prior to the kidney transplantation

• Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
• WBC< 2,500/mm^3, or platelet < 75,000/mm^3, or ANC < 1,300/mm^3
• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu Seun Kim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Countries

South Korea

Other Identifiers

211KT18008

Identifier Type: -

Identifier Source: org_study_id