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

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT00983034

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrotic Syndrome Glomerulonephritis Membranous Nephropathy	Drug: lansoprazole, amoxicillin, clarithromycin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Membranous nephropathy Patients with primary membranous nephropathy diagnosed by biopsy	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
Active Comparator: IgA nephropathy Patients with IgA nephropathy diagnosed by biopsy	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
Active Comparator: Focal segmental glomerulosclerosis Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy	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

Arm

Intervention/Treatment

Active Comparator: Membranous nephropathy

Patients with primary membranous nephropathy diagnosed by biopsy

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

Active Comparator: IgA nephropathy

Patients with IgA nephropathy diagnosed by biopsy

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

Active Comparator: Focal segmental glomerulosclerosis

Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy

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

Outcome Measures

Primary Outcome Measures

Daily proteinuria levels after Helicobacter Pylori eradication treatment [6 months]

Secondary Outcome Measures

Glomerular filtration rate [6 months]
Serum creatinine level [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University	Istanbul		Turkey	34390

Sponsors and Collaborators

Istanbul University

Investigators

Principal Investigator: Yasar Caliskan, MD, Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Principal Investigator: Berna Yelken, MD, Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Principal Investigator: Halil Yazici, MD, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
Study Director: Mehmet S Sever, Prof MD, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University