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

September 22, 2009 updated by: Istanbul University

Prospective Study of the Effects of Helicobacter Pylori Eradication on Renal Functions and 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34390
        • Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daily proteinuria levels after Helicobacter Pylori eradication treatment
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Glomerular filtration rate
Time Frame: 6 months
6 months
Serum creatinine level
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Yasar Caliskan, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 21, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimate)

September 23, 2009

Study Record Updates

Last Update Posted (Estimate)

September 23, 2009

Last Update Submitted That Met QC Criteria

September 22, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20061976

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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