Study of Atorvastatin Dose Dependent Reduction of Protein... | NCT00768638

Studies
Study of Atorvastatin Dose Dependent Reduction of Proteinuria

NCT00768638

Sponsor

Laval University

Status

Completed

Last Update Posted

Apr 29, 2015Estimated

Enrollment

23Actual

Phase

Phase 4

Conditions

Chronic Kidney Disease

Interventions

Atorvastatin
Atorvastatin

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

May 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Oct 7, 2008

First Submission Date that Met QC Criteria

Oct 7, 2008

First Posted Date

Oct 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2015

Last Update Posted Date

Apr 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atorvastatin 10mg	Active Comparator		Drug: Atorvastatin
Atorvastatin 40mg	Active Comparator		Drug: Atorvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin	Drug	Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)	Atorvastatin 10mg

Measure	Description	Time Frame
proteinuria		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohsen Agharazii, MD	Laval University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôtel-Dieu de Québec Hospital		Québec	Quebec	G1R2J6	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38018702	Derived	Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds