Randomized Controlled Study: Effect of Mycophenolatmofetil in Patients With Histologically Proven Chronic Allograft Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 86
- 主要终点
- course of renal function over 35 weeks
研究概览
简要总结
Prospective, randomised study: Effect of mycophenolatmofetil (MMF) and CNI withdrawal in patients with histologically proven chronic allograft nephropathy Indication: change in immunosuppressive treatment of chronic allograft nephropathy (CAN)after renal transplantation Hypothesis: Antimetabolite MMF is able to stop progression of CAN and improve blood pressure/ metabolic parameters and structural vessel wall changes
Primary Target:effects of CNI withdrawal and MMF on renal function: stabilisation and/or improvement Secondary Targets: Incidence of adverse events Evaluation of the calcineurin inhibitor free MMF treatment effects on blood pressure, lipids, glucose metabolism and on structural and functional vesselwallchanges Method:open prospective, randomized two-tailed, monocentric study
详细描述
Prospective, randomised study: Effect of mycophenolatmofetil in patients with histologically proven chronic allograft nephropathy
SYNOPSIS
Indication: change in treatment to improve the course of chronic allograft nephropathy
Method: open prospective, randomized two-tailed, non blinded monocentric study
Follow up period: 35 Weeks
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
- •Written informed consent Reduction of graft function: Increase of serum creatinine >= 0,1mg/dl/month in the previous 6 months before start of the study and/or new occurrence or increasing proteinuria in the last 6 months before start of the study Serum creatinine < 4 mg/dl Biopsy within the last 3 months histologically proved chronic allograft nephropathy >=1 year after renal allografting >=5 mg/day Prednisolone or equivalent dose
排除标准
- •Malignomas Gravidity or Lactation Participation in other studies Severe infections gastrointestinal Ulcer Age <18 and >70 years Leukopenia with less that 3000/dl leucocytes, Anaemia Hb > 9 g/dl Therapy with mycophenolatmofetil in the past 6 months Acute rejections in the past 6 months
结局指标
主要结局
course of renal function over 35 weeks
次要结局
- -malignomas
- after 35 weeks of follow up:
- incidence of
- -infections
- -gastrointestinal disorders
- number of antihypertensive drugs
- development of blood pressure over 35 weeks
- lipid state at entry and after 35 weeks
- blood glucose ,HBA1c at entry and after 35 weeks
- uric acid at entry and after 35 weeks
- -acute rejections
- area under the curve (AUC) determination of mycophenolic acid (MPA)
- vessel wall changes of the carotid arteries IMD , compliance, distensibility and hemodynamic parameters CO, CI, at entry and after after cni withdrawal and MMF addition
- Comparison of the development of 1/creatinine within each group at entry and 35 weeks after therapy conversion