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

Not Applicable

Completed

• Conditions: Nephrotic Syndrome; Glomerulonephritis; Membranous Nephropathy
• Interventions: Drug: lansoprazole, amoxicillin, clarithromycin

• Registration Number: NCT00983034
• Lead Sponsor: Istanbul University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2008-12
• Study Completion: 2009-07
• Status Verified: 2009-09
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-22
• Last Update Submitted: 2009-09-22
• Study First Posted: 2009-09-23
• Last Update Posted: 2009-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IgA nephropathy	lansoprazole, amoxicillin, clarithromycin	Patients with IgA nephropathy diagnosed by biopsy
Membranous nephropathy	lansoprazole, amoxicillin, clarithromycin	Patients with primary membranous nephropathy diagnosed by biopsy
Focal segmental glomerulosclerosis	lansoprazole, amoxicillin, clarithromycin	Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy

Primary Outcome Measures

Name	Time	Method
Daily proteinuria levels after Helicobacter Pylori eradication treatment	6 months

Secondary Outcome Measures

Name	Time	Method
Glomerular filtration rate	6 months
Serum creatinine level	6 months

Trial Locations

Locations (1)

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University; 🇹🇷 Istanbul, Turkey