EUCTR2007-005047-21-IT进行中（未招募）1 期
Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA II
IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点目标入组 40 人开始时间: 2008年7月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Age > 18 years - Clinical and ultrasound diagnosis of ADPKD - GFR <40 ml/min/1.73 m2 (estimated by the 4 variable MDRD equation) - Urinary protein excretion rate < 0.5 g/ 24 hrs - Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Diabetes - Urinary protein excretion rate >0.5 g/ 24 hrs or abnormal urinalysis suggestive of concomitant, clinically significant glomerular disease - Urinary tract lithiasis, infection or obstruction - Cancer - Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study - Pregnancy, lactation or child bearing potential and ineffective contraception (estrogen therapy in post menopausal women should not be stopped)
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