NCT00694863已完成2 期
Treatment With Synthetic Adrenocorticotropic Hormone (ACTH) in Patients With Membranous Nephropathy and High Risk for Renal Failure. A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Attainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule.
研究概览
简要总结
The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven idiopathic membranous nephropathy.
- •Nephrotic syndrome: proteinuria > 3.5 g/day and serum albumine < 30 g/l
- •Normal or mildly impaired renal function (eGFR > 60 ml/min, MDRD formula)
- •High risk for renal failure: beta-2-microglobulin excretion > 500 ng/min
- •Relative contra-indication for cyclophosphamide treatment:
- •fertility and wish for (future) family expanding
- •high age ( > 60 years)
- •former cyclophosphamide treatment
- •intolerance to cyclophosphamide
排除标准
- •Clinical,biochemical or histological signs of any underlying systemic disease
- •Any infectious disease (including latent tuberculosis and/or latent amoebiasis)
- •Active gastric or duodenal ulcers
- •Pregnancy, lactation, inadequate contraceptives
- •Clinical signs of renal vein thrombosis
- •Asthma and /or any allergic conditions or hypersensitivity reactions
- •Allergic reaction to synthetic ACTH in the past
研究组 & 干预措施
1
Experimental
In this open-label study all patients included are treated in the experimental group.
干预措施: tetracosactide hexacetaat (Drug)
结局指标
主要结局
Attainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule.
时间窗: 9 months
次要结局
- Efficacy of treatment with ACTH: number of remissions of proteinuria at the end of treatment(9 and 24 months)
研究者
研究点 (1)
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