A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 155
- 主要终点
- Correlation of allelic variants of MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GER and drug side effects.
研究概览
简要总结
This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.
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
- 13 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients participating in study ML17225.
排除标准
- 未提供
研究组 & 干预措施
2
干预措施: mycophenolate mofetil [CellCept] (Drug)
1
干预措施: mycophenolate mofetil [CellCept] (Drug)
1
干预措施: Cyclosporine or tacrolimus (Drug)
2
干预措施: Cyclosporine or tacrolimus (Drug)
3
干预措施: mycophenolate mofetil [CellCept] (Drug)
3
干预措施: Cyclosporine or tacrolimus (Drug)
结局指标
主要结局
Correlation of allelic variants of MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GER and drug side effects.
时间窗: Throughout study
次要结局
- Viral kinetics(Throughout study)