Kidney Transplant
Conditions
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 renal transplantation.
Interventions
DRUGtacrolimus tablet
* Orally, twice a day in the morning and night * After first dose 0.1mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 7\ 12ng/ml for 0 to 3months and then at 5\ 8ng/ml for 3 to 6months of study treatment.
* Orally, twice a day in the morning and night * After first dose 0.1mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 7\ 12ng/ml for 0 to 3months and then at 5\ 8ng/ml for 3 to 6months of study treatment.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax (Maximum concentration of drug in serum) | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours) | Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules |
| AUCt (Area under the plasma concentration-time curve from time zero to time t) | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours) | Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax (Maximum concentration of drug in serum) | At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules |
| AUCt (Area under the plasma concentration-time curve from time zero to time t) | At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours) | Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules |
| Dose normalized Cmax(Maximum concentration of drug in serum) | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules |
| Tmax (Time of peak concentration) | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules |
| Dose normalized Tmax(Time of peak concentration) | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules |
| Dose normalized AUC∞(Area under the plasma concentration-time curve from time zero to infinity) | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules |
| Dose normalized AUCt(Area under the plasma concentration-time curve from time zero to time t) | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules |
| AUC∞ (Area under the plasma concentration-time curve from time zero to infinity) | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules |
Countries
South Korea
Outcome results
None listed