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Study of Atorvastatin Dose Dependent Reduction of Proteinuria

Information source: Laval University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease

Intervention: Atorvastatin (Drug); Atorvastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Laval University

Official(s) and/or principal investigator(s):
Mohsen Agharazii, MD, Principal Investigator, Affiliation: Laval University

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Hôtel-Dieu de Québec Hospital, Quebec G1R2J6, Canada
Additional Information

Starting date: October 2008
Last updated: April 28, 2015

Page last updated: August 23, 2015

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