Status:
UNKNOWN
Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Kidney Transplant
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.
Detailed Description
This study is a Single center, randomized, open-label, Phase IV study to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) administration for 24 Weeks in patients after re...
Eligibility Criteria
Inclusion
- Over 19 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
- 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, Aspartate transaminase(AST), Alanine transaminase(ALT))is over 3 times than upper normal limit
- White Blood Cell(WBC) \<2.5 x10\^3/μL, or platelet \<75 x10\^3/μL
- 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 :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 10 2021
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04102943
Start Date
November 30 2017
End Date
January 10 2021
Last Update
January 9 2020
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea