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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Study of the Effects of Helicobacter Pylori Eradication on Renal Functions and Proteinuria in Patients With Membranous Nephropathy

Conditions
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Nephrotic Syndrome, Glomerulonephritis, Membranous Nephropathy

Intervention / Treatment
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* Drug: lansoprazole, amoxicillin, clarithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Membranous nephropathy<br>Patients with primary membranous nephropathy diagnosed by biopsy | Drug: lansoprazole, amoxicillin, clarithromycin<br>* lansoprazole, 30 mg twice daily, plus amoxicillin, 0.75 g twice daily, plus clarithromycin, 250 mg twice daily, for 14 days<br>|
| Active Comparator: IgA nephropathy<br>Patients with IgA nephropathy diagnosed by biopsy | Drug: lansoprazole, amoxicillin, clarithromycin<br>* lansoprazole, 30 mg twice daily, plus amoxicillin, 0.75 g twice daily, plus clarithromycin, 250 mg twice daily, for 14 days<br>|
| Active Comparator: Focal segmental glomerulosclerosis<br>Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy | Drug: lansoprazole, amoxicillin, clarithromycin<br>* lansoprazole, 30 mg twice daily, plus amoxicillin, 0.75 g twice daily, plus clarithromycin, 250 mg twice daily, for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily proteinuria levels after Helicobacter Pylori eradication treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular filtration rate |  | 6 months | 
| Serum creatinine level |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nephrotic syndrome, Helicobacter pylori infection, proteinuria, membranous nephropathy