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

This study has suspended participant recruitment.
(principle investigator moved, new investigators will join, insurance expired - project needs to be re-examined by an ethic committee)
Information provided by:
University Hospital, Strasbourg, France Identifier:
First received: August 28, 2006
Last updated: February 16, 2009
Last verified: February 2009
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 Phase
End Stage Renal Disease
Drug: losartan, hydrochlorothiazide
Drug: hydrochlorothiazide, losartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Specific Blockage of Angiotensine 2 and Podocyturia in Glomerular Nephropathies With Hypertension and Proteinuria

Resource links provided by NLM:

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: August 2006
Arms Assigned Interventions
Active Comparator: 1
losartan, hydrochlorothiazide
Drug: 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
Drug: 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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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
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Please refer to this study by its identifier: NCT00369538

Service de Néphrologie, Hôpital Civil, Hôpitaux Universitaires
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Luc FRANTZEN, MD Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: Emmanuel LAVOUE, Directeur Adjoint de la Recherche Clinique et de l'Innovation, University Hospital, Strasbourg, Fance Identifier: NCT00369538     History of Changes
Other Study ID Numbers: 3742
Study First Received: August 28, 2006
Last Updated: February 16, 2009

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urination Disorders
Urological Manifestations
Signs and Symptoms
Angiotensin Receptor Antagonists
Angiotensin II
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Vasoconstrictor Agents processed this record on May 25, 2017