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

Primary Purpose

Nephrotic Syndrome, Glomerulonephritis, Membranous Nephropathy

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

lansoprazole, amoxicillin, clarithromycin

About this trial

This is an interventional supportive care trial for Nephrotic Syndrome focused on measuring nephrotic syndrome, Helicobacter pylori infection, proteinuria, membranous nephropathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Membranous nephropathy

IgA nephropathy

Focal segmental glomerulosclerosis

Arm Description

Patients with primary membranous nephropathy diagnosed by biopsy

Patients with IgA nephropathy diagnosed by biopsy

Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy

Outcomes

Primary Outcome Measures

Daily proteinuria levels after Helicobacter Pylori eradication treatment

Secondary Outcome Measures

Glomerular filtration rate

Serum creatinine level

Full Information

NCT ID

NCT00983034

First Posted

September 21, 2009

Last Updated

September 22, 2009

Sponsor

Istanbul University

1. Study Identification

Unique Protocol Identification Number

NCT00983034

Brief Title

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

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Istanbul University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nephrotic Syndrome, Glomerulonephritis, Membranous Nephropathy

Keywords

nephrotic syndrome, Helicobacter pylori infection, proteinuria, membranous nephropathy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Membranous nephropathy

Arm Type

Active Comparator

Arm Description

Patients with primary membranous nephropathy diagnosed by biopsy

Arm Title

IgA nephropathy

Arm Type

Active Comparator

Arm Description

Patients with IgA nephropathy diagnosed by biopsy

Arm Title

Focal segmental glomerulosclerosis

Arm Type

Active Comparator

Arm Description

Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy

Intervention Type

Drug

Intervention Name(s)

lansoprazole, amoxicillin, clarithromycin

Intervention Description

lansoprazole, 30 mg twice daily, plus amoxicillin, 0.75 g twice daily, plus clarithromycin, 250 mg twice daily, for 14 days

Primary Outcome Measure Information:

Title

Daily proteinuria levels after Helicobacter Pylori eradication treatment

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Glomerular filtration rate

Time Frame

6 months

Title

Serum creatinine level

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yasar Caliskan, MD

Organizational Affiliation

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Berna Yelken, MD

Organizational Affiliation

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Halil Yazici, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mehmet S Sever, Prof MD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

24707402

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.

Results Reference

derived

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

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