Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Kidney Transplant
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2020
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT03749356
Start Date
September 5 2018
End Date
December 4 2020
Last Update
January 5 2021
Active Locations (1)
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1
Severance Hospital, Yonsei University Health System
Seoul, South Korea