Study of Atorvastatin Dose Dependent Reduction of Proteinuria
NCT ID: NCT00768638
Last Updated: 2015-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
23 participants
INTERVENTIONAL
2008-10-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Atorvastatin 10mg
Atorvastatin
Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)
Atorvastatin 40mg
Atorvastatin
Atorvastatin 40mg 1co id (40mg active) Placebo 10mg 1co id (10mg inactive)
Interventions
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Atorvastatin
Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)
Atorvastatin
Atorvastatin 40mg 1co id (40mg active) Placebo 10mg 1co id (10mg inactive)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Laval University
OTHER
Responsible Party
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Karine Marquis
Professionnelle de recherche
Principal Investigators
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Mohsen Agharazii, MD
Role: PRINCIPAL_INVESTIGATOR
Laval University
Locations
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Hôtel-Dieu de Québec Hospital
Québec, Quebec, Canada
Countries
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References
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Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
Other Identifiers
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NRA2580119
Identifier Type: -
Identifier Source: org_study_id
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