Study of Atorvastatin Dose Dependent Reduction of Proteinuria (SARP)

This study is currently recruiting participants.
Verified April 2014 by Laval University
Sponsor:
Information provided by (Responsible Party):
Karine Marquis, Laval University
ClinicalTrials.gov Identifier:
NCT00768638
First received: October 7, 2008
Last updated: April 4, 2014
Last verified: April 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


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 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atorvastatin 10mg Drug: Atorvastatin
Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)
Other Name: lipitor 10mg
Active Comparator: Atorvastatin 40mg Drug: Atorvastatin
Atorvastatin 40mg 1co id (40mg active) Placebo 10mg 1co id (10mg inactive)
Other Name: lipitor 40mg

  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: Karine Marquis, PHD 418-525-4444 ext 12969 karine.marquis@crhdq.ulaval.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: Karine Marquis, Professionnelle de recherche, Laval University
ClinicalTrials.gov Identifier: NCT00768638     History of Changes
Other Study ID Numbers: NRA2580119
Study First Received: October 7, 2008
Last Updated: April 4, 2014
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
Chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Proteinuria
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Renal Insufficiency
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014