EUCTR2005-004469-40-BE进行中（未招募）不适用
Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to ACE-inhibitors alone in the treatment of de novo nephrotic syndrome due to idiopathic membranous glomerulopathy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •1) Male and female patients aged from 18 to 70 years old.
- •2) Patients with initial (in order to exclude those with relapses, and to make the group more homogeneous) clinical diagnosis of de novo nephrotic syndrome (i.e. proteinuria > 3 g/d., hypoalbuminemia, hyperlipidemia) and biopsy proven membranous nephropathy.
- •3) Renal function > 50 ml/min. per 1.73 m² body surface area as measured by a 24 hrs. urine creatinine clearance.
- •4) Written informed consent should be obtained from participating patients
- •5) Females of childbearing age should use appropriate contraception.
- •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
- •1) Current malignancies or history of previous malignancies except for treated basal or squamous cell skin carcinoma.
- •2) Metabolic disorders (including diabetes mellitus patients) or systemic diseases (e.g. lupus,…)
- •3) Active liver diseases
- •4) Presence of another kidney disease
- •5) Disorders of the central nervous system
- •6) The use of immunosuppressive therapy 3 months prior to the start of the study
- •7) Kidney transplanted patients
- •8) Active infection at study entry
- •9) Known hypersensitivity to ACE-inhibitors or contraindication for ACE-inhibitors
- •10) Renal artery stenosis
- •11) Pregnancy or wish to become pregnant during the study period
- •12) Non-compliance or psychological disorders which may impair the compliance of the patient
- •13) HIV-positive patients
研究者
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