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

NCT00983034 | Completed

• 1 other identifier: 20061976
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrotic Syndrome; Glomerulonephritis; Membranous Nephropathy

Keywords

nephrotic syndrome; Helicobacter pylori infection; proteinuria; membranous nephropathy

Outcome Measures

Primary Outcomes (1)

• Daily proteinuria levels after Helicobacter Pylori eradication treatment

  6 months

Secondary Outcomes (2)

• Glomerular filtration rate

  6 months

• Serum creatinine level

  6 months

Study Arms (3)

Membranous nephropathy

ACTIVE COMPARATOR

Patients with primary membranous nephropathy diagnosed by biopsy

Drug: lansoprazole, amoxicillin, clarithromycin

IgA nephropathy

ACTIVE COMPARATOR

Patients with IgA nephropathy diagnosed by biopsy

Drug: lansoprazole, amoxicillin, clarithromycin

Focal segmental glomerulosclerosis

ACTIVE COMPARATOR

Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy

Drug: lansoprazole, amoxicillin, clarithromycin

Interventions

lansoprazole, amoxicillin, clarithromycin 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; IgA nephropathy; Membranous nephropathy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

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

Istanbul, 34390, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 24707402 DERIVED

MeSH Terms

Conditions

Nephrotic Syndrome; Glomerulonephritis; Glomerulonephritis, Membranous; Proteinuria

Interventions

Lansoprazole; Amoxicillin; Clarithromycin

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Mehmet S Sever, Prof MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 23, 2009
• Study Start: March 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: July 1, 2009
• Last Updated: September 23, 2009

Record last verified: 2009-09

Locations

TU (1)