APOMYGRE : Multicenter, Randomized, Open-Label Study of MMF Therapeutic Follow-up's Interest in the the 12 First Months in Kidney Transplantation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 137
- 试验地点
- 12
- 主要终点
- immunosuppressant treatment fealure (kidney rejection, adverse events, death, graft lost).
研究概览
简要总结
Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and then minimize side effects in the long term. However definitive proof is still lacking. We conducted a randomized study in 11 french centers and included 137 kidney transplant recipients (PRA<50%) receiving a classical immunosuppressant regimen with basiliximab, Csa, MMF and steroids. The "fixed dose" group received 2 g of MMF a day. The "concentration controlled" group received MMF dose adapted to the area under the concentration curve (AUC) of MPA, with a target of 40 h.mg/L. After transplantation AUCs were calculated with a Bayesian estimator using a 3-point limited sampling strategy on day 7, 14, and months 1, 3, 6 , 12 in both groups (values note communicated to the physicians in the "fixed dose" group.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients received a first or a second kidney transplantation
- •patients with panel reactive antibody <or= 50 %
- •patients with cellcept treatment since fewer 3 days
- •patients receiving or being received ciclosporine treatment
- •patients without retention, important hepatic cytolysis
- •patients without post-surgical complication or intercurrent disease
- •informed consent signed
排除标准
- •patients included in other study
- •patients with MMF or mycophenolic acid hypersensibility or MMF contraindication
- •patients with gastroduodenal disorder before the beginning of the study
- •pregnant women or without contraception
- •patients with rapamycin or analogous
- •patients with toxicomania or psychiatric disorder
结局指标
主要结局
immunosuppressant treatment fealure (kidney rejection, adverse events, death, graft lost).
次要结局
- renal fonction evolution