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)
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00369538
First received: August 28, 2006
Last updated: February 16, 2009
Last verified: February 2009
  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 4

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

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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

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

ClinicalTrials.gov processed this record on October 20, 2014