Study of Atorvastatin Dose Dependent Reduction of Proteinuria - Full Text View

Study of Atorvastatin Dose Dependent Reduction of Proteinuria (SARP)

This study is currently recruiting participants.

Verified by Laval University, December 2008

First Received: October 7, 2008 Last Updated: December 16, 2008 History of Changes

Sponsor:	Laval University
Information provided by:	Laval University
ClinicalTrials.gov Identifier:	NCT00768638

Purpose

Randomized controlled double blind study of parallel groups to evaluate the comparative effects of low-dose of atorvastatin on proteinuria in patients with stage 3 or 4 chronic kidney disease.

Condition	Intervention	Phase
Chronic Kidney Disease	Drug: Atorvastatin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	The Renal Protective Effects of Low-Dose and High-Dose Atorvastatin in Patients With Glomerular Disease and Proteinuria: a Randomized Controlled Double Blinded Study

Resource links provided by NLM:

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:

proteinuria [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Atorvastatin 10mg: Active Comparator	Drug: Atorvastatin Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)
Atorvastatin 40mg: Active Comparator	Drug: Atorvastatin Atorvastatin 40mg 1co id (40mg active) Placebo 10mg 1co id (10mg inactive)

Eligibility

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

Criteria

Inclusion Criteria:

Age of 18 and over
Stage 3 or 4 chronic kidney disease (modified MDRD)
proteinuria of > 1g/d on ACEi and/or ARB, or proteinuria of > 1g/d with intolerance or contraindication to ACEi and/or ARB
blood pressure < 130/80 mmHg or < 140/90 mmHg in patients with five or more antihypertensive drugs
stable renal function

Exclusion Criteria:

rapid progression of renal failure
immunosuppressive therapy within the past 3 months
need a renal replacement therapy within 8 months
definite history of chronic liver disease, or abnormal liver function
evidence of active inflammatory muscle disease
definite previous adverse reaction to a statin
concurrent treatment with a contraindicated drug (fibrate, macrolide antibiotic, systemic use of imidazole or triazole antifungals, protease-inhibitors, ciclosporin)
child bearing potential
known to be poorly compliant with clinic visits or prescribed medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768638

Contacts

Contact: Mohsen Agharazii, MD	418-525-4444 ext 15585	mohsen.agharazii@crhdq.ulaval.ca
Contact: Johanne Blouin, SC	418-525-4444 ext 16487	johanne.blouin@chuq.qc.ca

Locations

Canada
Hôtel-Dieu de Québec Hospital	Recruiting
Quebec, Canada, G1R2J6
Contact: Mohsen Agharazii, MD (418) 525-4444 ext 15585 mohsen.agharazii@crhdq.ulaval.ca
Principal Investigator: Mohsen Agharazii, MD

Sponsors and Collaborators

Laval University

Investigators

Principal Investigator:

Mohsen Agharazii, MD

Laval University

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Québec (CHUQ) ( Mohsen Agharazii )
Study ID Numbers:	NRA2580119
Study First Received:	October 7, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00768638 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Laval University:

Chronic kidney disease

Additional relevant MeSH terms:

Antimetabolites
Renal Insufficiency
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Antilipemic Agents
Kidney Failure, Chronic
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

Urological Manifestations
Signs and Symptoms
Proteinuria
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Kidney Diseases
Atorvastatin
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010