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Specific Blockage of Angiotensine 2 and Podocyturia in Glomerular Nephropathies With Hypertension and Proteinuria

This study is not yet open for participant recruitment.
Verified by University Hospital, Strasbourg, France, August 2006

Sponsored by: University Hospital, Strasbourg, France
Information provided by: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00369538
  Purpose

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.


Condition Intervention
Proteinuria
Hypertension
End Stage Renal Disease
Drug: losartan and hydrochlorothiazide

MedlinePlus related topics:   High Blood Pressure   

ChemIDplus related topics:   Hydrochlorothiazide    Losartan    Losartan potassium    Angiotensin II    Angiotensin II, ile(5)-   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:   Specific Blockage of Angiotensine 2 and Podocyturia in Glomerular Nephropathies With Hypertension and Proteinuria

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Podocyturia

Secondary Outcome Measures:
  • Proteinuria;
  • selectivity index of proteinuria
  • arterial blood pressure

Estimated Enrollment:   20
Study Start Date:   September 2006

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369538

Contacts
Contact: Luc FRANTZEN, MD     33.3.88.11.52.89     luc.frantzen@chru-strasbourg.fr    
Contact: Aurore STEINMETZ     33.3.88.11.57.95     aurore.steinmetz@chru-strasbourg.fr    

Locations
France
Service de Néphrologie, Hôpital Civil, Hôpitaux Universitaires     Not yet recruiting
      Strasbourg, France, 67091
      Contact: Luc FRANTZEN, MD     33.3.88.11.52.89     luc.frantzen@chru-strasbourg.fr    
      Contact: Aurore STEINMETZ     33.3.88.11.57.95     aurore.steinmetz@chru-strasbourg.fr    
      Principal Investigator: Luc FRANTZEN, MD            
      Sub-Investigator: Thierry HANNEDOUCHE, MD            
      Sub-Investigator: Pascal BOUSQUET, MD            
      Sub-Investigator: Christian BRANDT, MD            

Sponsors and Collaborators
University Hospital, Strasbourg, France

Investigators
Principal Investigator:     Luc FRANTZEN, MD     Hôpitaux Universitaires de Strasbourg    
  More Information


Study ID Numbers:   3742
First Received:   August 28, 2006
Last Updated:   August 28, 2006
ClinicalTrials.gov Identifier:   NCT00369538
Health Authority:   France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Podocyte – podocyturia – microparticles – angiotensin receptor antagonist – glomerulosclerosis  
Patients presenting with stable glomerular nephropathy with proteinuria, normal or slightly altered renal function, with hypertension  

Study placed in the following topic categories:
Renal Insufficiency
Losartan
Urination Disorders
Kidney Failure, Chronic
Vascular Diseases
Angiotensin II
Hydrochlorothiazide
Signs and Symptoms
Proteinuria
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Hypertension
Kidney Failure

Additional relevant MeSH terms:
Membrane Transport Modulators
Urological Manifestations
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Sodium Chloride Symporter Inhibitors
Physiological Effects of Drugs
Diuretics
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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