Study of Atorvastatin Dose Dependent Reduction of Proteinuria (SARP)
This study is currently recruiting participants.
Verified May 2013 by Laval University
Sponsor:
Laval University
Information provided by (Responsible Party):
Karine Marquis, Laval University
ClinicalTrials.gov Identifier:
NCT00768638
First received: October 7, 2008
Last updated: May 9, 2013
Last verified: May 2013
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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:
MedlinePlus related topics:
Chronic Kidney Disease
Drug Information available for:
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: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (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: | May 9, 2013 |
| 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 May 16, 2013