Study of Atorvastatin Dose Dependent Reduction of Proteinuria (SARP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00768638
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : April 29, 2015
Information provided by (Responsible Party):
Karine Marquis, Laval University

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Atorvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2008
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. proteinuria [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00768638

Hôtel-Dieu de Québec Hospital
Quebec, Canada, G1R2J6
Sponsors and Collaborators
Laval University
Principal Investigator: Mohsen Agharazii, MD Laval University

Responsible Party: Karine Marquis, Professionnelle de recherche, Laval University Identifier: NCT00768638     History of Changes
Other Study ID Numbers: NRA2580119
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015

Keywords provided by Karine Marquis, Laval University:
Chronic kidney disease

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