NCT01339468已完成4 期
A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf® (Tacrolimus) in de Novo Living Donor Liver Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration
研究概览
简要总结
The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject receiving a primary, partial liver graft from a living donor
- •subject must receive the first dose of tacrolimus and corticosteroids after operation and are expected to be maintained on tacrolimus throughout the study. MMF could be combined
排除标准
- •subjects receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation)
- •subjects receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
- •subjects allergic or intolerant to macrolide antibiotics or tacrolimus
- •subjects requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation
- •subjects with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin
- •subjects with systemic infection requiring treatment, except viral hepatitis
- •subjects with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
- •subjects with serum creatinine > 1.5mg/dl
- •subjects taking or having taken potassium preserved diuretics
- •subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
- •subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days
- •subjects or donors known to be HIV positive
- •donors known to be HBV, HCV positive and/or IgM positive of CMV, EBV
研究组 & 干预措施
Arm 1
Experimental
Intravenous Prograf therapy followed by oral Advagraf therapy
干预措施: Advagraf (Drug)
Arm 1
Experimental
Intravenous Prograf therapy followed by oral Advagraf therapy
干预措施: Prograf (Drug)
Arm 2
Active Comparator
Intravenous Prograf therapy followed by oral Prograf therapy
干预措施: Prograf (Drug)
结局指标
主要结局
AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration
时间窗: Day 6 and day 21
次要结局
- Cmax (maximum concentration) of tacrolimus plasma concentration(Day 6 and day 21)
- Time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)(up to 24 weeks)
- Safety assessed by the incidence of adverse events and lab-tests(up to 24 weeks)
- Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)(up to 24 weeks)
研究者
相似试验
已完成
4 期
Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.Kidney TransplantNCT04102943Chong Kun Dang Pharmaceutical128
已完成
4 期
A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation RecipientsLiver TransplantationKidney TransplantationNCT05152628Astellas Pharma China, Inc.55
已完成
1 期
Bioequivalence Study of Tacrolimus in Healthy VolunteersHealthy VolunteersNCT04725682Food and Drug Administration (FDA)67
招募中
不适用
Tacrolimus Pharmacokinetic SubpopulationsKidney Transplant Failure and RejectionImmunosuppression-related Infectious DiseaseNCT04526431University Hospital, Grenoble180
已完成
4 期
Pharmacokinetic Studies of Tacrolimus in Transplant PatientsKidney Transplant RecipientsLiver Transplant RecipientsNCT01889758University of Cincinnati78