Study of Atorvastatin Dose Dependent Reduction of Proteinuria (SARP)

April 28, 2015 updated by: Karine Marquis, Laval University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1R2J6
        • Hôtel-Dieu de Québec Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atorvastatin 10mg
Drug: Atorvastatin
Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)
Other Names:
  • lipitor 10mg
Drug: Atorvastatin
Atorvastatin 40mg 1co id (40mg active) Placebo 10mg 1co id (10mg inactive)
Other Names:
  • lipitor 40mg
Active Comparator: Atorvastatin 40mg
Drug: Atorvastatin
Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)
Other Names:
  • lipitor 10mg
Drug: Atorvastatin
Atorvastatin 40mg 1co id (40mg active) Placebo 10mg 1co id (10mg inactive)
Other Names:
  • lipitor 40mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proteinuria
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Mohsen Agharazii, MD, Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 7, 2008

First Submitted That Met QC Criteria

October 7, 2008

First Posted (Estimate)

October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRA2580119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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