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Completed

NCT Number: NCT00983034

The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous Nephropathy

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.

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Key information

Conditions

Nephrotic Syndrome Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, Membranous Immune System Diseases Kidney Diseases Male Urogenital Diseases Membranous Nephropathy Nephritis Nephrosis Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University

Istanbul, 34390, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

lansoprazole, amoxicillin, clarithromycin

Drug

lansoprazole, 30 mg twice daily, plus amoxicillin, 0.75 g twice daily, plus clarithromycin, 250 mg twice daily, for 14 days

Primary outcomes

  1. Daily proteinuria levels after Helicobacter Pylori eradication treatment

    Time frame: 6 months

Secondary outcomes

  1. Glomerular filtration rate

    Time frame: 6 months

  2. Serum creatinine level

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Sep 23, 2009
Registry last updated
Sep 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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