Study of Atorvastatin Dose Dependent Reduction of Proteinuria

The Renal Protective Effects of Low-dose and High-dose Atorvastatin in Patients With Glomerular Disease and Proteinuria: a Randomized Controlled Double Blinded Study

Sponsors

Lead Sponsor: Laval University

Source Laval University
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.

Overall Status Completed
Start Date October 2008
Completion Date June 2014
Primary Completion Date May 2014
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
proteinuria 6 months
Enrollment 23
Condition
Intervention

Intervention Type: Drug

Intervention Name: Atorvastatin

Description: Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)

Arm Group Label: Atorvastatin 10mg

Other Name: lipitor 10mg

Intervention Type: Drug

Intervention Name: Atorvastatin

Description: Atorvastatin 40mg 1co id (40mg active) Placebo 10mg 1co id (10mg inactive)

Arm Group Label: Atorvastatin 40mg

Other Name: lipitor 40mg

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mohsen Agharazii, MD Principal Investigator Laval University
Location
Facility: Hôtel-Dieu de Québec Hospital
Location Countries

Canada

Verification Date

April 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Laval University

Investigator Full Name: Karine Marquis

Investigator Title: Professionnelle de recherche

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Atorvastatin 10mg

Type: Active Comparator

Label: Atorvastatin 40mg

Type: Active Comparator

Acronym SARP
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov