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临床试验/EUCTR2008-001647-19-NL
EUCTR2008-001647-19-NL进行中(未招募)不适用

Treatment with synthetic adrenocoticotropic hormone (ACTH) in patients with membranous nephropathy and high risk for renal failure. A pilot study. - ACTHiMe

Radboud University Nijmegen Medical Center0 个研究点开始时间: 2008年6月4日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • -Age 18-75 years
  • -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, eGFR by
  • MDRD formula)
  • -High risk for renal failure: beta-2-microglobulin excretion > 500 ng/min
  • -Relative contra-indication for cyclophosphamide treatment :
  • a.fertility and wish for (future) family expanding
  • b.high age ( > 60 years)
  • c.former cyclophosphamide treatment
  • d.intolerance to cyclophosphamide
  • 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

  • -Clinical, biochemical or histological signs of any underlying systemic
  • -Any infectious disease (including latent tuberculosis and/or latente
  • amoebiasis)
  • -Active gastic or duodenal ulcers
  • -Pregnancy, lactation, inadequate contraceptives
  • -Clinical signs of renal vein thrombosis
  • -Astma and /or any allergic conditions or hypersensitivity reactions
  • -Allergic reaction to synthetic ACTH in the past

研究者

发起方
Radboud University Nijmegen Medical Center

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