Study of Atorvastatin Dose Dependent Reduction of Proteinuria (SARP)

Laval University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00768638

NRA2580119

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Atorvastatin 10mg

Active Comparator group

Treatment:

Drug: Atorvastatin

Drug: Atorvastatin

Atorvastatin 40mg

Active Comparator group

Treatment:

Drug: Atorvastatin

Drug: Atorvastatin