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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00983034
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : September 23, 2009
Sponsor:
Information provided by:
Istanbul University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : March 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Daily proteinuria levels after Helicobacter Pylori eradication treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Glomerular filtration rate [ Time Frame: 6 months ]
  2. Serum creatinine level [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983034


Locations
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Turkey
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
Istanbul, Turkey, 34390
Sponsors and Collaborators
Istanbul University
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yasar Caliskan, Division of Nephrology, Department of Intenal Medicine, Istanbul Faculty of Medicine, Istanbul University
ClinicalTrials.gov Identifier: NCT00983034    
Other Study ID Numbers: 20061976
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: September 23, 2009
Last Verified: September 2009
Keywords provided by Istanbul University:
nephrotic syndrome
Helicobacter pylori infection
proteinuria
membranous nephropathy
Additional relevant MeSH terms:
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Kidney Diseases
Proteinuria
Nephrotic Syndrome
Nephrosis
Glomerulonephritis
Glomerulonephritis, Membranous
Urologic Diseases
Urination Disorders
Urological Manifestations
Nephritis
Autoimmune Diseases
Immune System Diseases
Amoxicillin
 Clarithromycin
Lansoprazole
Dexlansoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors