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The purpose of this study is to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus1 | Experimental | 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. |
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| Tacrolimus2 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus tablet | Drug |
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| 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) |
| 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) |
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Inclusion Criteria:
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| tacrolimus capsules | Drug |
|
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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) |