NCT02311010Unknown4 期
Influence of Recipient Cytochrome P450 3A5 Polymorphism on the Metabolism of Prolonged Release Tacrolimus Administered de Novo After Renal Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of tacrolimus
研究概览
简要总结
To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of the genetic Cyp 450 3A5 polymorphism of the recipient.
The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or second Kidney Transplantation from deceased or living donor
排除标准
- •Donor age < 5 years.
- •Patients who require plasma exchange because of high immunological risk
研究组 & 干预措施
CYP 3 A 5 *3/*3
Active Comparator
CYP 3 A 5 *3/*3 will receive 0,25 mg/kg of Advagraf®
干预措施: Advagraf (Drug)
CYP 3 A 5 *1/*3
Active Comparator
CYP 3 A 5 *1/*3 will receive 0,30 mg/kg of Advagraf®
干预措施: Advagraf (Drug)
CYP 3 A 5 *1/*1
Active Comparator
CYP 3 A 5 *1/*1 will receive 0,35 mg/kg of Advagraf®
干预措施: Advagraf (Drug)
结局指标
主要结局
Pharmacokinetics of tacrolimus
时间窗: 1 year
tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year
次要结局
- Kidney graft function(1 year)
研究者
Prof Martine De Meyer
MD
Université Catholique de Louvain
研究点 (1)
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