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Study of Atorvastatin Dose Dependent Reduction of Proteinuria (SARP)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Atorvastatin
Atorvastatin
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôtel-Dieu de Québec Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Atorvastatin 10mg

Atorvastatin 40mg

Arm Description

Outcomes

Primary Outcome Measures

proteinuria

Secondary Outcome Measures

Full Information

First Posted
October 7, 2008
Last Updated
April 28, 2015
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT00768638
Brief Title
Study of Atorvastatin Dose Dependent Reduction of Proteinuria
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin 10mg
Arm Type
Active Comparator
Arm Title
Atorvastatin 40mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
lipitor 10mg
Intervention Description
Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
lipitor 40mg
Intervention Description
Atorvastatin 40mg 1co id (40mg active) Placebo 10mg 1co id (10mg inactive)
Primary Outcome Measure Information:
Title
proteinuria
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen Agharazii, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôtel-Dieu de Québec Hospital
City
Quebec
ZIP/Postal Code
G1R2J6
Country
Canada

12. IPD Sharing Statement

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Study of Atorvastatin Dose Dependent Reduction of Proteinuria

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