Pilot Trial for Implementation of a MPA PK Monitoring Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of subjects with an average AUC between 30-60 ng x hr/mL
研究概览
简要总结
This study is a prospective interventional trial of de novo renal transplant recipients, aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a clinically applicable fashion.
详细描述
Mycophenolate mofetil or MMF (CellCept® by Roche) is the mofetil ester of mycophenolic acid (MPA), the active immunosuppressant.
MMF significantly decreases the episodes of acute rejection in kidney transplant patients; but as with any medication without adequate pharmacokinetic drug monitoring, the issue of under or over immunosuppression arises. For this reason, the biggest challenge lies with establishing a feasible mean of MPA pharmacokinetic monitoring. Thus far no study has shown that measuring MPA trough levels alone correlates with rejection, unlike MPA Area Under the concentration time Curve (AUC), due to the large incidence of inter- and intra-patient variability.
This is the first prospective blinded trial set up to analyze the correlation between individualized MPA AUC and trough levels of kidney transplant patients in hopes of establishing a more efficacious way of monitoring MPA. MPA target trough levels that correspond to AUC greater than 30 mg x h/L could then be utilized as maintenance measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary or secondary cadaveric or living donor kidney recipients
- •On Cellcept
排除标准
- •Multi organ recipients
- •Documented non-compliance
- •Not on a calcineurin inhibitor
- •GFR <25 ml/min by Cockcroft Gault equation
- •Serum albumin <2.5 mg/dl
- •Active serious digestive disorder
研究组 & 干预措施
CellCept + Prograf
Standard of Care Regime
干预措施: Mycophenolate mofetil + Tacrolimus (Drug)
CellCept + Neoral
Standard of Care Regime
干预措施: Mycophenolate mofetil + Cyclosporin (Drug)
结局指标
主要结局
Number of subjects with an average AUC between 30-60 ng x hr/mL
时间窗: 7 months
次要结局
- Rate of acute rejection of transplanted kidney(7 months)
- Number of MPA related toxicities(7 months)
- Number of dose changes required to obtain MPA AUC target in the first month(7 months)