Study of Atorvastatin Dose Dependent Reduction of Proteinuria

Chronic Kidney Disease Clinical Trial

— SARP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768638
• Other study ID #: NRA2580119
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2008
• Last updated: April 28, 2015
• Start date: October 2008
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Canada	Hôtel-Dieu de Québec Hospital	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proteinuria		6 months	No