Nephrotic SyndromeNCT00983034

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

A study testing lansoprazole, amoxicillin, clarithromycin in people with Nephrotic Syndrome and Glomerulonephritis, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Nephrotic Syndrome, Glomerulonephritis, Membranous Nephropathy
What is being tested?: lansoprazole, amoxicillin, clarithromycin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Mar 2006to Jul 2009
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
Istanbul, 34390

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Conditions: Nephrotic Syndrome, Glomerulonephritis, Membranous Nephropathy
Being tested: lansoprazole, amoxicillin, clarithromycin
Keywords: nephrotic syndrome, Helicobacter pylori infection, proteinuria, membranous nephropathy
Medical subject headings: Nephrotic Syndrome, Glomerulonephritis, Glomerulonephritis, Membranous, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00983034
Study group	Role	What they receive
Membranous nephropathy	Active comparator	Patients with primary membranous nephropathy diagnosed by biopsy Receives: Drug: lansoprazole, amoxicillin, clarithromycin
IgA nephropathy	Active comparator	Patients with IgA nephropathy diagnosed by biopsy Receives: Drug: lansoprazole, amoxicillin, clarithromycin
Focal segmental glomerulosclerosis	Active comparator	Patients with primary focal segmental glomerulosclerosis diagnosed by biopsy Receives: Drug: lansoprazole, amoxicillin, clarithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Daily proteinuria levels after Helicobacter Pylori eradication treatment
Measured: 6 months

Secondary outcomes (2)

Glomerular filtration rate
Measured: 6 months
Serum creatinine level
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Jul 2009

First posted23 Sep 2009 (estimated)
Study startMar 2006
Primary completionDec 2008
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
More trials run by Istanbul UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00983034
Sponsor's protocol ID: 20061976
Status last verified: Sep 2009
First submitted: 21 Sep 2009
Last updated: 23 Sep 2009
Results posted: No
Data monitoring committee: No

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.
PubMed 24707402

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nephrotic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Study of the Effects of Helicobacter Pylori Eradication on Renal Functions and Proteinuria in Patients With Membranous Nephropathy
ClinicalTrials.gov ID: NCT00983034
Acronym / sponsor ID: 20061976
Conditions: Nephrotic Syndrome, Glomerulonephritis, Membranous Nephropathy
Keywords: nephrotic syndrome, Helicobacter pylori infection, proteinuria, membranous nephropathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Istanbul UniversityUniversity, hospital or other
Study start: Mar 2006
Primary completion: Dec 2008 (actual)
Study completion: Jul 2009 (actual)
First posted: 23 Sep 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Membranous nephropathy	Active comparator	Drug: lansoprazole, amoxicillin, clarithromycinPatients with primary membranous nephropathy diagnosed by biopsy
IgA nephropathy	Active comparator	Drug: lansoprazole, amoxicillin, clarithromycinPatients with IgA nephropathy diagnosed by biopsy
Focal segmental glomerulosclerosis	Active comparator	Drug: lansoprazole, amoxicillin, clarithromycinPatients with primary focal segmental glomerulosclerosis diagnosed by biopsy

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lansoprazole, amoxicillin, clarithromycinlansoprazole, 30 mg twice daily, plus amoxicillin, 0.75 g twice daily, plus clarithromycin, 250 mg twice daily, for 14 days	Drug	Focal segmental glomerulosclerosis, IgA nephropathy, Membranous nephropathy

Primary outcome

Daily proteinuria levels after Helicobacter Pylori eradication treatment
Time frame: 6 months

2 secondary outcomes

Glomerular filtration rate
Time frame: 6 months
Serum creatinine level
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2009.
Derived from this study: PubMed 24707402Caliskan 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.

Related trials for Nephrotic Syndrome

Active, not recruitingPhase 2/3
Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome
Steroid-Dependent Nephrotic Syndrome, Steroid-Sensitive Nephrotic Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Immune System Related Kidney Disease
Kidney Disease, Nephrotic Syndrome
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yasar Caliskan, MD principal investigator

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Berna Yelken, MD principal investigator

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Halil Yazici, MD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing lansoprazole, amoxicillin, clarithromycin in people with Nephrotic Syndrome and Glomerulonephritis, run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily proteinuria levels after Helicobacter Pylori eradication treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00983034, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2009; AzTrials last refreshed its copy on 8 Nov 2026.