- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00369538
Specific Blockage of Angiotensine 2 and Podocyturia in Glomerular Nephropathies With Hypertension and Proteinuria
February 16, 2009 updated by: University Hospital, Strasbourg, France
Chronic glomerular diseases are one of the main causes leading to end stage renal disease (ESRD).
Hypertension and proteinuria are two modifiable factors promoting the progression of ESRD.
Podocyte are terminally differentiated epithelial cells and play a central role in the progression of chronic kidney disease and in the development of glomerulosclerosis.
The presence of podocyte in urines (podocyturia) has been documented by several teams with continuous and regular podocyturia during glomerular disease.
This facts suggests that podocyturia could become a marker of podocyte loss and glomerular damage.
In our university hospital, we developed a technique to evaluate the number of microparticles (cellular fragments) in different biologic samples.
The podocytary origin of microparticles will be determinated thanks to specific antibodies.
The aim of the present study is: i) to quantify podocyturia during glomerular nephropathies by dosing podocyte microparticles ii) to study the relationship between podocyturia and other biologic markers such as proteinuria iii) to evaluate the effect of angiotensine 2 blockage on podocyturia.
This is an open-labelled randomized monocenter cross-over study.
Twenty subjects with hypertension and glomerular nephropathy characterized by proteinuria and a normal or slightly altered renal function will be included.
Patients will be treated successively by an angiotensin receptor blocker (ARB), losartan and by a thiazide, hydrochlorothiazide, (after a wash out period).
We will study the impact of these two therapies on podocyturia.
Results will be compared with others markers like proteinuria (and its selectivity).
We may finally dispose of a non invasive urinary marker of podocyte lesions responsible for glomerulosclerosis and for ESRD progression.
Moreover mechanism of nephroprotection of the ARB may be more comprehensive.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Strasbourg, France, 67091
- Service de Néphrologie, Hôpital Civil, Hôpitaux Universitaires
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Hypertension (TAs > 130, TAd > 80mmHg or under antihypertensive treatment)
- Glomerular nephropathy, proteinuria > 1 g/day, serum creatinin < 200 µmol/L ;
- Informed consent given ;
- No contraindication for ARB and hydrochlorothiazide ;
- Efficient contraception for women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
losartan, hydrochlorothiazide
|
Two administrations of losartan per day,up to 100mg per day, during 2 months, followed by a wash-out during 1 month, and then one administration of hydrochlorothiazide, 25 mg per day during 2 months
|
ACTIVE_COMPARATOR: 2
hydrochlorothiazide, losartan
|
One administration of hydrochlorothiazide, 25 mg per day during 2 months, followed by a wash-out during 1 month, and then, two administrations of losartan per day,up to 100mg per day, during 2 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Podocyturia
|
Secondary Outcome Measures
Outcome Measure |
---|
Proteinuria;
|
selectivity index of proteinuria
|
arterial blood pressure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Luc FRANTZEN, MD, Hôpitaux universitaires de Strasbourg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Study Registration Dates
First Submitted
August 28, 2006
First Submitted That Met QC Criteria
August 28, 2006
First Posted (ESTIMATE)
August 29, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
February 18, 2009
Last Update Submitted That Met QC Criteria
February 16, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Urological Manifestations
- Renal Insufficiency
- Urination Disorders
- Renal Insufficiency, Chronic
- Hypertension
- Kidney Diseases
- Kidney Failure, Chronic
- Proteinuria
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Losartan
- Hydrochlorothiazide
Other Study ID Numbers
- 3742
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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