Prospective Evaluation of Proteinuria and Renal Function in Non-diabetic Patients With Progressive Renal Disease

NCT ID: NCT00296400

Last Updated: 2011-06-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in non-diabetes with moderate proteinuria and hypercholesterolaemia.

Detailed Description

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Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Rosuvastatin

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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Inclusion Criteria

* greater than or equal to 18 years of age
* Hyperlipidemia
* Urinary protein

Exclusion Criteria

* Previous rosuvastatin treatment \< 6 months prior to Visit 1
* Statin intolerance
* Severe hypertension
* Diabetes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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AstraZeneca Crestor Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Avondale, Arizona, United States

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Phoenix, Arizona, United States

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Pasadena, California, United States

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Riverside, California, United States

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Clearwater, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Augusta, Georgia, United States

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Topeka, Kansas, United States

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Columbia, Maryland, United States

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Springfield, Massachusetts, United States

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Detroit, Michigan, United States

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Columbia, Missouri, United States

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Orchard Park, New York, United States

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Winston-Salem, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Pittsburgh, Pennsylvania, United States

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Columbia, South Carolina, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Gig Harbor, Washington, United States

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Milwaukee, Wisconsin, United States

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Curitiba, Paraná, Brazil

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São Paulo, São Paulo, Brazil

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Blagoevgrad, , Bulgaria

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Burgas, , Bulgaria

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Gabrovo, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Veliko Tarnovo, , Bulgaria

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Vancouver, British Columbia, Canada

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St. John's, Newfoundland and Labrador, Canada

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Courtice, Ontario, Canada

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East York, Ontario, Canada

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Oakville, Ontario, Canada

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Oshawa, Ontario, Canada

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Richmond Hill, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Copenhagen, , Denmark

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Fredericia, , Denmark

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Herlev, , Denmark

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Holbæk, , Denmark

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Roskilde, , Denmark

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Viborg, , Denmark

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Berlin, , Germany

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Cloppenburg, , Germany

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Demmin, , Germany

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Düsseldorf, , Germany

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Elsenfeld, , Germany

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Göttingen, , Germany

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Hanover, , Germany

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Würzburg, , Germany

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Ajka, , Hungary

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Baja, , Hungary

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Balatonfüred, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Eger, , Hungary

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Gyula, , Hungary

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Gy�r, , Hungary

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Keszthely, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Szolnok, , Hungary

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Szombathely, , Hungary

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Zalaegerszeg, , Hungary

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Bergamo, BG, Italy

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Bologna, BO, Italy

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Brescia, BS, Italy

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Acireale, CT, Italy

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Foggia, FG, Italy

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Florence, FI, Italy

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Parma, PR, Italy

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Reggio Calabria, RC, Italy

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Sassari, SS, Italy

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Teramo, TE, Italy

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Torino, TO, Italy

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Castelfranco Veneto, TV, Italy

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Treviso, TV, Italy

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Mestre, VE, Italy

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Zapopan, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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D.F, Mexico, Mexico

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San Luis Potos�, Mexico, Mexico

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Cuernavaca, Morelos, Mexico

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Aguascalientes, , Mexico

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Durango, , Mexico

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Brasov, Brașov County, Romania

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Cluj-Napoca, Cluj, Romania

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Constanța, Constanța County, Romania

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Suceava, Suceava, Romania

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Timișoara, Timiș County, Romania

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Bucharest, , Romania

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Craiova, , Romania

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Iași, , Romania

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Johannesburg, Gauteng, South Africa

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Pretoria, South Africa, South Africa

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Parow, W Cape, South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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Countries

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United States Brazil Bulgaria Canada Denmark Germany Hungary Italy Mexico Romania South Africa

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)

de Zeeuw D, Anzalone DA, Cain VA, Cressman MD, Heerspink HJ, Molitoris BA, Monyak JT, Parving HH, Remuzzi G, Sowers JR, Vidt DG. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial. Lancet Diabetes Endocrinol. 2015 Mar;3(3):181-90. doi: 10.1016/S2213-8587(14)70246-3. Epub 2015 Feb 4.

Reference Type DERIVED
PMID: 25660356 (View on PubMed)

Other Identifiers

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PLANET II

Identifier Type: -

Identifier Source: secondary_id

D3569C00011

Identifier Type: -

Identifier Source: org_study_id

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