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

This study has been completed.

Sponsor:

Information provided by:

Istanbul University

ClinicalTrials.gov Identifier:

NCT00983034

First received: September 21, 2009

Last updated: September 22, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 21, 2009

Last Updated Date

September 22, 2009

Start Date ^ICMJE

March 2006

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Daily proteinuria levels after Helicobacter Pylori eradication treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00983034 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Glomerular filtration rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Serum creatinine level [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Nephrotic Syndrome
Glomerulonephritis
Membranous Nephropathy

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Membranous nephropathy
Patients with primary membranous nephropathy diagnosed by biopsy

Intervention: Drug: lansoprazole, amoxicillin, clarithromycin
Active Comparator: IgA nephropathy
Patients with IgA nephropathy diagnosed by biopsy

Intervention: Drug: lansoprazole, amoxicillin, clarithromycin
Active Comparator: Focal segmental glomerulosclerosis
Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy

Intervention: Drug: lansoprazole, amoxicillin, clarithromycin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT Number ^ICMJE

NCT00983034

Other Study ID Numbers ^ICMJE

20061976

Has Data Monitoring Committee

Responsible Party

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

Study Sponsor ^ICMJE

Istanbul University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Istanbul University

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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