Anti-Proteinuric Response to ACEI, ARB and Diuretics Combination.

This study has been terminated.

( difficulty in patients's inclusion )

First Received: September 13, 2005 Last Updated: February 3, 2009 History of Changes

Sponsored by:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00200694

Purpose

Determine the best strategy for proteinuria lowering in patients with proteinuria > 1 g/day receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of diuretic dosage.

Condition	Intervention	Phase
Heavy Proteinuria	Drug: ramipril 5 mg + valsartan 80 mg/day, Drug: ramipril 10 mg + valsartan 160 mg/day, Drug: ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Resource links provided by NLM:

Drug Information available for: Furosemide Ramipril Valsartan

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Estimated Enrollment:	18
Study Start Date:	March 2005
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

proteinuria > 1 g/day with ramipril 5 + valsartan 80 mg/day for 2 months
proteinuria changes < 50% on 3 separate dosages over 2 months.

Exclusion criteria:

age < 18 or > 80 years systolic BP < 110 or ≥ 140 mmHg, serum creatinine > 250 mmole/L
serum creatinine increase on ramipril + valsartan > 20%
intolerance to ACEI or ARB

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200694

Locations

France
CHU de Nantes
Nantes, France

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

Vincent LM Esnault, MD PHD

CHU de Nantes

More Information

No publications provided

Study ID Numbers:	BRD 03-5-D
Study First Received:	September 13, 2005
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00200694 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:

Proteinuria
ACEI
ARB

diuretics
blood pressure
renal failure

Study placed in the following topic categories:

Urination Disorders
Diuretics
Cardiovascular Agents
Antihypertensive Agents
Furosemide
Ramipril
Protease Inhibitors

Signs and Symptoms
Proteinuria
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Valsartan
Kidney Failure

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Urination Disorders
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Ramipril
Pharmacologic Actions
Protease Inhibitors

Urological Manifestations
Signs and Symptoms
Proteinuria
Urologic Diseases
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Valsartan

ClinicalTrials.gov processed this record on July 02, 2009