Study of Atorvastatin Dose Dependent Reduction of Proteinuria (SARP)

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Renal Insufficiency
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014