EUCTR2012-000550-60-AT进行中（未招募）1 期
Pulsed oral sirolimus in autosomal dominant polycystic kidney disease - The Vienna RAP Study
Medizinische Universität Wien, Klinische Abteilung für Nephrologie und Dialyse, Universitätsklinik für Innere Medizin 30 个研究点目标入组 68 人开始时间: 2013年11月27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
- 68
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
- 性别
- All
入选标准
- •ADPKD, as confirmed by history, ultrasound, computed- or magnetic resonance tomography
- •Eighteen years of age, or older
- •Baseline estimated glomerular filtration rate (eGFR; 4 variable MDRD equation) below 60 mL/min per 1.73m2
- •Negative serum pregnancy test prior to administration of sirolimus and agreement to use contraception throughout the study and three months after
- •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 68
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •Need for renal replacement therapy
- •Pregnancy/lactation
- •Plans to become pregnant in the near future
- •Refusal to use sufficient contraception
- •Proteinuria as defined as proteine:creatinine ratio >1000 or >1g/d, respectively
- •History of life threatening complications of ADPKD
- •Evidence of active systemic- or localized major infection
- •Evidence of infiltrate or consolidation on chest X-ray
- •Use of any investigational drug or -treatment up to 4 weeks prior to enrolment and during the study
- •Known allergy/hypersensitivity to sirolimus and its derivatives
- •Medication that will interfere with the CYP3A4/CYP3A5 system
- •Total white blood cell count below or equal to 3000/mm3
- •Platelet count below or equal to 100.000/mm3
- •Fasting triglycerides above or equal to 400 mg/dL
- •Fasting total cholesterol above or equal to 300 mg/dL
- •Concomitant glomerular diseases
- •Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study
- •History of malignancy, with the exception of adequately treated basal cell- and squamous cell carcinoma of the skin
- •HIV positivity
研究者
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