|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 |
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations| France | |
| Service de Néphrologie, Hôpital Civil, Hôpitaux Universitaires | |
| Strasbourg, France, 67091 | |
| 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 |
| ClinicalTrials.gov Identifier: | NCT00369538 History of Changes |
| Other Study ID Numbers: | 3742 |
| Study First Received: | August 28, 2006 |
| Last Updated: | February 16, 2009 |
| Health Authority: | France: Ministry of Health |
|
Podocyte - podocyturia - microparticles - angiotensin receptor antagonist - glomerulosclerosis Patients presenting with stable glomerular nephropathy with proteinuria, normal or slightly altered renal function, with hypertension |
|
Hypertension Kidney Diseases Kidney Failure, Chronic Proteinuria Vascular Diseases Cardiovascular Diseases Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Urination Disorders Urological Manifestations Signs and Symptoms Angiotensin II Hydrochlorothiazide Losartan |
Angiotensin Receptor Antagonists Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers |