Clinical trial NCT00983034: The Effects of Helicobacter Pylori Eradication on Proteinuria in Patients With Membranous Nephropathy
Official title: Prospective Study of the Effects of Helicobacter Pylori Eradication on Renal Functions and Proteinuria in Patients With Membranous Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrotic Syndrome
Glomerulonephritis
Membranous Nephropathy
Keywords: nephrotic syndrome
Helicobacter pylori infection
proteinuria
membranous nephropathy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Daily proteinuria levels after Helicobacter Pylori eradication treatment
timeFrame: 6 months
Secondary outcomes:
measure: Glomerular filtration rate
timeFrame: 6 months
measure: Serum creatinine level
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
Study officials:
affiliation: Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
name: Yasar Caliskan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
name: Berna Yelken, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
name: Halil Yazici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
name: Mehmet S Sever, Prof MD
role: STUDY_DIRECTOR
References:
citation: 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.