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

Chong Kun Dang Pharmaceutical128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

128

Conditions

Kidney Transplant

Interventions

tacrolimus tabletDRUG

* 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.

tacrolimus capsulesDRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Cmax (Maximum concentration of drug in serum)

Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

Time frame: 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

Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)

Secondary Outcomes

Tmax (Time of peak concentration)

Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)

Data from ClinicalTrials.gov

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