Study of Atorvastatin Dose Dependent Reduction of Proteinuria
SARP
The Renal Protective Effects of Low-dose and High-dose Atorvastatin in Patients With Glomerular Disease and Proteinuria: a Randomized Controlled Double Blinded Study
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 7, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedApril 29, 2015
April 1, 2015
5.6 years
October 7, 2008
April 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proteinuria
6 months
Study Arms (2)
Atorvastatin 10mg
ACTIVE COMPARATORAtorvastatin 40mg
ACTIVE COMPARATORInterventions
Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Study Sites (1)
Hôtel-Dieu de Québec Hospital
Québec, Quebec, G1R2J6, Canada
Related Publications (1)
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.
PMID: 38018702DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohsen Agharazii, MD
Laval University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professionnelle de recherche
Study Record Dates
First Submitted
October 7, 2008
First Posted
October 8, 2008
Study Start
October 1, 2008
Primary Completion
May 1, 2014
Study Completion
June 1, 2014
Last Updated
April 29, 2015
Record last verified: 2015-04