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

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ClinicalTrials.gov Identifier: NCT00983034
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : September 23, 2009
Sponsor:
Information provided by:
Istanbul University

Tracking Information
First Submitted Date  ICMJE September 21, 2009
First Posted Date  ICMJE September 23, 2009
Last Update Posted Date September 23, 2009
Study Start Date  ICMJE March 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)		 Daily proteinuria levels after Helicobacter Pylori eradication treatment [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
  • Glomerular filtration rate [ Time Frame: 6 months ]
  • Serum creatinine level [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Arms  ICMJE
  • 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 * 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.

*   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
Actual Enrollment  ICMJE
 (submitted: September 22, 2009)		 70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00983034
Other Study ID Numbers  ICMJE 20061976
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yasar Caliskan, Division of Nephrology, Department of Intenal Medicine, Istanbul Faculty of Medicine, Istanbul University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Istanbul University
Original Study Sponsor  ICMJE Same as current
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
PRS Account Istanbul University
Verification Date September 2009

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