Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.

Detailed Description
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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.

Official Title
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Single Center, Randomized, Open-label, Phase IV Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus Tablet(TacroBell) in Kidney Transplant Recipients.

Conditions
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Kidney Transplant

Intervention / Treatment
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* Drug: tacrolimus tablet
* Drug: tacrolimus capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus1<br>Tacrolimus 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 achieve 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. | Drug: tacrolimus tablet<br>* 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.<br>* Other names: tacrobell tablet;|
| Active Comparator: Tacrolimus2<br>Tacrolimus Cap 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 achieve 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. | Drug: tacrolimus capsules<br>* 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.<br>* Other names: prograf capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum concentration of drug in serum) | Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours) | 
| AUCt (Area under the plasma concentration-time curve from time zero to time t) | Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax (Time of peak concentration) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours) | 
| AUC∞ (Area under the plasma concentration-time curve from time zero to infinity) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours) | 
| Cmax (Maximum concentration of drug in serum) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours) | 
| AUCt (Area under the plasma concentration-time curve from time zero to time t) | Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours) | 
| Tmax (Time of peak concentration) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours) | 
| AUC∞ (Area under the plasma concentration-time curve from time zero to infinity) | Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours) | 
| Dose normalized Cmax(Maximum concentration of drug in serum) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | 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) | 
| Dose normalized AUCt(Area under the plasma concentration-time curve from time zero to time t) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | 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) | 
| Dose normalized Tmax(Time of peak concentration) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | 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) | 
| Dose normalized AUC∞(Area under the plasma concentration-time curve from time zero to infinity) | Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules | 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) |