Viewing Study NCT00369538



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Study NCT ID: NCT00369538
Status: SUSPENDED
Last Update Posted: 2009-02-18
First Post: 2006-08-28

Brief Title: Specific Blockage of Angiotensine 2 and Podocyturia in Glomerular Nephropathies With Hypertension and Proteinuria
Sponsor: University Hospital Strasbourg France
Organization: University Hospital Strasbourg France

Study Overview

Official Title: Specific Blockage of Angiotensine 2 and Podocyturia in Glomerular Nephropathies With Hypertension and Proteinuria
Status: SUSPENDED
Status Verified Date: 2009-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: principle investigator moved new investigators will join insurance expired - project needs to be re-examined by an ethic committee
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None