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

This study is ongoing, but not recruiting participants.

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

Drug Information available for: Valsartan Ramipril Furosemide

U.S. FDA Resources

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

Further study details as provided by Nantes University Hospital:

Estimated Enrollment:

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.

Exclusion Criteria:

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

Study ID Numbers:	BRD 03-5-D
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00200694
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:

Signs and Symptoms
Proteinuria
Urologic Diseases
Urination Disorders

Furosemide
Ramipril
Valsartan
Kidney Failure

Additional relevant MeSH terms:

Urological Manifestations
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009