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

• Status: Completed
• Trial end date: 2020-12-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Tacrolimus

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