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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 )
Study NCT00369538   Information provided by University Hospital, Strasbourg, France
First Received: August 28, 2006   Last Updated: February 16, 2009   History of Changes

August 28, 2006
February 16, 2009
August 2006
 
Podocyturia
Same as current
Complete list of historical versions of study NCT00369538 on ClinicalTrials.gov Archive Site
  • Proteinuria;
  • selectivity index of proteinuria
  • arterial blood pressure
Same as current
 
Specific Blockage of Angiotensine 2 and Podocyturia in Glomerular Nephropathies With Hypertension and Proteinuria
Specific Blockage of Angiotensine 2 and Podocyturia in Glomerular Nephropathies With Hypertension and Proteinuria

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.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
  • Proteinuria
  • Hypertension
  • End Stage Renal Disease
  • Drug: losartan, hydrochlorothiazide
  • Drug: hydrochlorothiazide, losartan
  • Active Comparator: losartan, hydrochlorothiazide
  • Active Comparator: hydrochlorothiazide, losartan
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Suspended
20
 
 
  • 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00369538
Emmanuel LAVOUE, Directeur Adjoint de la Recherche Clinique et de l'Innovation, University Hospital, Strasbourg, Fance
3742
University Hospital, Strasbourg, France
 
Principal Investigator: Luc FRANTZEN, MD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP