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Specific Blockage of Angiotensine 2 and Podocyturia in Glomerular Nephropathies With Hypertension and Proteinuria
This study has been suspended.
( principle investigator moved, new investigators will join, insurance expired - project needs to be re-examined by an ethic committee )
First Received: August 28, 2006   Last Updated: February 16, 2009   History of Changes
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 Phase
Proteinuria
Hypertension
End Stage Renal Disease
Drug: losartan, hydrochlorothiazide
Drug: hydrochlorothiazide, losartan
Phase IV

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

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
1: Active Comparator
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
2: Active Comparator
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

  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

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

No publications provided

Responsible Party: University Hospital, Strasbourg, Fance ( Emmanuel LAVOUE, Directeur Adjoint de la Recherche Clinique et de l'Innovation )
Study ID Numbers: 3742
Study First Received: August 28, 2006
Last Updated: February 16, 2009
ClinicalTrials.gov Identifier: NCT00369538     History of Changes
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
Sodium Chloride Symporter Inhibitors
Diuretics
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II
Hydrochlorothiazide
Angiotensin II Type 1 Receptor Blockers
Signs and Symptoms
Proteinuria
Urologic Diseases
Renal Insufficiency, Chronic
Anti-Arrhythmia Agents
Kidney Diseases
Hypertension
Kidney Failure

Additional relevant MeSH terms:
Renal Insufficiency
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Kidney Failure, Chronic
Membrane Transport Modulators
Signs and Symptoms
Urologic Diseases
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Kidney Diseases
Losartan
Urination Disorders
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Urological Manifestations
Proteinuria
Renal Insufficiency, Chronic
Natriuretic Agents
Kidney Failure
Hypertension

ClinicalTrials.gov processed this record on July 02, 2009