Single Center, Randomized, Open-label, Phase IV Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus Tablet(TacroBell) in Kidney Transplant Recipients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Cmax (Maximum concentration of drug in serum)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tacrolimus2
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.
干预措施: tacrolimus capsules (Drug)
Tacrolimus1
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.
干预措施: tacrolimus tablet (Drug)
结局指标
主要结局
Cmax (Maximum concentration of drug in serum)
时间窗: 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)
时间窗: 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
次要结局
- AUC∞ (Area under the plasma concentration-time curve from time zero to infinity)(At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours))
- Cmax (Maximum concentration of drug in serum)(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)(At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours))
- 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))
- 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))
- 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))
- 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))
- Tmax (Time of peak concentration)(At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours))
- Tmax (Time of peak concentration)(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)(At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours))