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
  Purpose

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 Intervention
Nephrotic Syndrome
Glomerulonephritis
Membranous Nephropathy
Drug: lansoprazole, amoxicillin, clarithromycin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Istanbul University:

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

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

Enrollment: 70
Study Start Date: March 2006
Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983034

Locations
Turkey
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
  More Information

No publications provided

Responsible Party: Yasar Caliskan, Division of Nephrology, Department of Intenal Medicine, Istanbul Faculty of Medicine, Istanbul University
ClinicalTrials.gov Identifier: NCT00983034     History of Changes
Other Study ID Numbers: 20061976
Study First Received: September 21, 2009
Last Updated: September 22, 2009
Health Authority: Turkey: Ethics Committee

Keywords provided by Istanbul University:
nephrotic syndrome
Helicobacter pylori infection
proteinuria
membranous nephropathy

Additional relevant MeSH terms:
Glomerulonephritis
Glomerulonephritis, Membranous
Kidney Diseases
Nephrotic Syndrome
Proteinuria
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Nephrosis
Urination Disorders
Urological Manifestations
Signs and Symptoms
Amoxicillin
Clarithromycin
Lansoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014