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

NCT ID: NCT00983034

Last Updated: 2009-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Nephrotic Syndrome Glomerulonephritis Membranous Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Membranous nephropathy

Patients with primary membranous nephropathy diagnosed by biopsy

Group Type ACTIVE_COMPARATOR

lansoprazole, amoxicillin, clarithromycin

Intervention Type DRUG

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

IgA nephropathy

Patients with IgA nephropathy diagnosed by biopsy

Group Type ACTIVE_COMPARATOR

lansoprazole, amoxicillin, clarithromycin

Intervention Type DRUG

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

Focal segmental glomerulosclerosis

Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy

Group Type ACTIVE_COMPARATOR

lansoprazole, amoxicillin, clarithromycin

Intervention Type DRUG

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

Interventions

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lansoprazole, amoxicillin, clarithromycin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Yasar Caliskan, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Berna Yelken, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Halil Yazici, MD

Role: PRINCIPAL_INVESTIGATOR

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

Mehmet S Sever, Prof MD

Role: STUDY_DIRECTOR

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

Locations

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

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Caliskan B, Yazici H, Caliskan Y, Ozluk Y, Gulluoglu M, Kilicaslan I, Turkmen A, Sever MS. The Effects of Helicobacter pylori Eradication on Proteinuria in Patients with Primary Glomerulonephritis. Int J Nephrol. 2014;2014:180690. doi: 10.1155/2014/180690. Epub 2014 Feb 24.

Reference Type DERIVED
PMID: 24707402 (View on PubMed)

Other Identifiers

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20061976

Identifier Type: -

Identifier Source: org_study_id

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