Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- AUC 0-24h of tacrolimus at Day 8 and Day 84
研究概览
简要总结
A pharmacokinetics and pharmacogenetics study to complement the current knowledge of tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after renal transplantation.
Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus immediate release (Prograf®)
详细描述
Multicentre open-labeled randomized pharmacokinetic (PK) and pharmacogenetic (PG) study to compare Advagraf and Prograf immediate post-transplantation (Day 8) and steady-state (Day 84) systemic exposure.
Tacrolimus PK profile, tacrolimus systemic exposure assessed by Limited Samples Strategies (LSS) (i.e.: Bayesian estimators (BE) and Multilinear Regressions (MLR)), and impact of CYP3A5 and ABCB1 genetic polymorphisms on tacrolimus PK will also be determined to improve the optimal dose of Advagraf® for kidney transplant patients.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult recipients aged between 18 to 70
- •Primary renal transplantation
- •Cadaver or living transplantation or living (non HLA identical) donor with compatible ABO blood type.
- •absence of anti-LHA antibodies in lymphocytotoxicity and Luminex
- •Negative cross-match in cytotoxicity
- •Negative pregnancy test for female patients of childbearing potential, and agreement to practice effective birth control during the study
排除标准
- •Combined transplantation
- •Renal bigraft
- •History of any other transplantation
- •Receiving a graft from a non-heart-beating donor.
- •Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation
- •Patient who received within one month prior to study an inductor of CYP50 3A or requiring during the study an inhibitor of CYP50 3A or of P-gp.
- •Significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
- •Subject or donor known to be HIV positive
- •Active viral hepatitis (VHB, VHC) at randomisation
- •Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, or mycophenolate mofetil or any of the product excipients
- •Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully.
- •Current participation in any other clinical study
- •Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
- •Patient not able to comply with the study procedures
- •Breast-feeding mother
研究组 & 干预措施
Prograf
干预措施: Prograf Capsule (Drug)
Advagraf
干预措施: Advagraf Capsule (Drug)
结局指标
主要结局
AUC 0-24h of tacrolimus at Day 8 and Day 84
时间窗: 3 months
次要结局
- AUC 24h of tacrolimus using limited samples strategies (LSS) at Day 8 and Day 84(3 months)