Study of Atorvastatin Dose Dependent Reduction of Proteinuria
Information source: Laval University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease
Intervention: Atorvastatin (Drug); Atorvastatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Laval University Official(s) and/or principal investigator(s):
Mohsen Agharazii, MD, Principal Investigator, Affiliation: Laval University
Overall contact:
Mohsen Agharazii, MD, Phone: 418-525-4444, Ext: 15585, Email: mohsen.agharazii@crhdq.ulaval.ca
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Primary outcome: proteinuria
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Mohsen Agharazii, MD, Phone: 418-525-4444, Ext: 15585, Email: mohsen.agharazii@crhdq.ulaval.ca
Hôtel-Dieu de Québec Hospital, Quebec G1R2J6, Canada; Recruiting
Mohsen Agharazii, MD, Phone: (418) 525-4444, Ext: 15585, Email: mohsen.agharazii@crhdq.ulaval.ca
Mohsen Agharazii, MD, Principal Investigator
Additional Information
Starting date: October 2008
Ending date: May 2010
Last updated: December 16, 2008
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