An Open-labelled Multicenter Randomized Study on the Efficacy of Everolimus in Reducing Total Native Kidney Volume in Kidney Transplanted Patients With Autosomal Dominant Polycystic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Total native kidney volume variation
研究概览
简要总结
The investigators multicenter randomized open-labelled study will investigate the efficacy of an everolimus based immunosuppression in reducing total native kidney volume in kidney recipients with autosomal dominant polycystic kidney disease compared to a calcineurin inhibitor-based immunosuppression.
详细描述
Kidney graft recipients receiving a firs kidney graft (between 6 months and 5 years post-transplantation) will be randomized 1:1 to receive an everolimus based immunosuppression (in association with steroids and mycophenolate mofetil) or to continue their calcineurin inhibitor-based immunosuppression regimen. The primary objective will be the reduction of total native kidney volume after a 2-years treatment period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 75 years-old
- •recipients of a first kidney graft between 6 month and 5 years ago with a stable eGFR above 30 ml/min/1,73m2
- •contraception for female recipients to avoid pregnancy
- •valid health Insurance during the study period
排除标准
- •signed informed consent not obtained
研究组 & 干预措施
Everolimus
everolimus based immunosuppression
干预措施: Everolimus (Drug)
Calcineurin
Calcineurin inhibitors maintenance
干预措施: Calcineurin inhibitors maintenance (Drug)
结局指标
主要结局
Total native kidney volume variation
时间窗: 24 months after randomization
measurements of total native kidney volume with a MRI
次要结局
- Volume variation of the biggest liver cyst(24 months after randomization)
- Interstitial Fibrosis/Tubular Atrophy variation(24 months after randomization)
- % interstitial fibrosis using Red Sirius staining(24 months after randomization)
- Calculated Estimated Glomerular Filtration rate(At baseline, 1 month, 6 months, 12 months, 18 and 24 months)
- Measured Glomerular Filtration rate(At baseline and 24 months)
- Proteinuria(At baseline, 1 month, 6 months, 12 months, 18 and 24 months)
- systolic and diastolic blood pressure(At baseline, 1 month, 6 months, 12 months, 18 and 24 months)
- Occurrence of diabetes or hyperlipidemia(up to 24 months)
- Occurrence of neoplasia(up to 24 months)
- Development of HLA Donor Specific Antibody (DSA)(At baseline, 1 month, 6 months, 12 months, 18 and 24 months)