EUCTR2006-003427-37-IT进行中(未招募)1 期
Sirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - ND
IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点目标入组 16 人开始时间: 2006年12月27日最近更新:
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
- 16
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 - 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 - Overt proteinuria urinary protein excretion rate 1g/24 hours 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
研究者
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Pulsed oral sirolimus in autosomal dominant polycystic kidney diseaseAutosomal dominant polycystic kidney disease (ADPKD) is a genetic disorder characterized by the development and uncontrolled proliferation of innumerable epithelial-lined cysts that stem from renal tubular cells, which compress and/or destroy vital renal tissue with a gradual decline in renal function, and terminal kidney failure with the need for renal reaplacement therapy. As yet, other than supportive care there is no viable therapy.MedDRA version: 20.0Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominantSystem Organ Class: 100000004850EUCTR2012-000550-60-ATMedizinische Universität Wien, Klinische Abteilung für Nephrologie und Dialyse, Universitätsklinik für Innere Medizin 368
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