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

Nephrotic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983034
• Other study ID #: 20061976
• Status: Completed
• Phase: N/A
• First received: September 21, 2009
• Last updated: September 22, 2009
• Start date: March 2006
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, Membranous
• Kidney Diseases
• Membranous Nephropathy
• Nephrosis
• Nephrotic Syndrome
• Proteinuria

Intervention

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

Locations

Country	Name	City	State
Turkey	Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily proteinuria levels after Helicobacter Pylori eradication treatment		6 months	Yes
Secondary	Glomerular filtration rate		6 months	Yes
Secondary	Serum creatinine level		6 months	Yes