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临床试验/NCT00983034
NCT00983034已完成不适用

Prospective Study of the Effects of Helicobacter Pylori Eradication on Renal Functions and Proteinuria in Patients With Membranous Nephropathy

Istanbul University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Daily proteinuria levels after Helicobacter Pylori eradication treatment

研究概览

简要总结

Membranous nephropathy (MN) may also be secondary to many other diseases (e.g., infections, drugs, neoplasms and autoimmune diseases). In this study, the presence of Helicobacter Pylori (H. pylori) antigen was investigated in renal tissue from needle biopsy samples, and the prevalence of H. pylori infection and the effects of H. pylori eradication on proteinuria level in patients with MN will be investigated.

详细描述

Membranous nephropathy (MN) is a common cause of nephrotic syndrome in adults. It is thought to be mainly a primary or idiopathic form; however, it may also be secondary to many other diseases (e.g., infections, drugs, neoplasms and autoimmune diseases). In this study, the presence of Helicobacter Pylori antigen was investigated in renal tissue from needle biopsy samples, and the prevalence of H. pylori infection and the effects of H. pylori eradication on proteinuria level in patients with MN will be investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-70 years
  • Nondiabetic patients
  • Patients with primary glomerulonephritis
  • Clinical diagnosis of membranous nephropathy, IgA nephropathy or focal segmental glomerulosclerosis confirmed by biopsy
  • Glomerular filtration rate > 30 mL/min
  • Patients who did not receive Helicobacter pylori eradication therapy within the last three months before enrollment in study

排除标准

  • Patients with secondary glomerulonephritis
  • Glomerular filtration rate < 30 mL/min
  • Patients who received Helicobacter pylori eradication therapy within the last three months before enrollment in study
  • Patients with a history of gastric surgery
  • Patients without an informed consent

研究组 & 干预措施

Membranous nephropathy

Active Comparator

Patients with primary membranous nephropathy diagnosed by biopsy

干预措施: lansoprazole, amoxicillin, clarithromycin (Drug)

IgA nephropathy

Active Comparator

Patients with IgA nephropathy diagnosed by biopsy

干预措施: lansoprazole, amoxicillin, clarithromycin (Drug)

Focal segmental glomerulosclerosis

Active Comparator

Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy

干预措施: lansoprazole, amoxicillin, clarithromycin (Drug)

结局指标

主要结局

Daily proteinuria levels after Helicobacter Pylori eradication treatment

时间窗: 6 months

次要结局

  • Glomerular filtration rate(6 months)
  • Serum creatinine level(6 months)

研究者

申办方类型
Other

研究点 (1)

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