Study of Atorvastatin Dose Dependent Reduction of Proteinuria

NCT ID: NCT00768638

Last Updated: 2015-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Atorvastatin 10mg

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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

Atorvastatin 40mg

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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

Interventions

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Atorvastatin

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

Intervention Type DRUG

Atorvastatin

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

Intervention Type DRUG

Other Intervention Names

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lipitor 10mg lipitor 40mg

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Karine Marquis

Professionnelle de recherche

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohsen Agharazii, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Hôtel-Dieu de Québec Hospital

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 38018702 (View on PubMed)

Other Identifiers

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NRA2580119

Identifier Type: -

Identifier Source: org_study_id

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