Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease

NCT ID: NCT00296374

Last Updated: 2011-09-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-03-31

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 patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Rosuvastatin 10 mg

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

10 mg oral dose administered once daily for 52 weeks

2

Rosuvastatin 40 mg

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks

3

Atorvastatin 80 mg

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks

Interventions

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Rosuvastatin

10 mg oral dose administered once daily for 52 weeks

Intervention Type DRUG

Rosuvastatin

20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks

Intervention Type DRUG

Atorvastatin

40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks

Intervention Type DRUG

Other Intervention Names

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Crestor Crestor Lipitor

Eligibility Criteria

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Inclusion Criteria

* hyperlipidemia
* urinary protein
* diabetes

Exclusion Criteria

* previous rosuvastatin treatment \< 6 months prior to Visit 1
* statin intolerance
* severe hypertension
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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Responsibility Role SPONSOR

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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Jonesboro, Arkansas, United States

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Pasadena, California, United States

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Riverside, California, United States

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Santa Ana, California, United States

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West Hills, California, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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West Palm Beach, Florida, United States

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Augusta, Georgia, United States

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Topeka, Kansas, 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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St Louis, Missouri, United States

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Orchard Park, New York, United States

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Stony Brook, New York, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Kettering, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Columbia, South Carolina, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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La Plata, , Argentina

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Morón, , Argentina

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Quilmes, , Argentina

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Curitiba, , Brazil

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Fortaleza, , Brazil

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Goiânia, , Brazil

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Recife, , Brazil

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São Paulo, , Brazil

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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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Courtice, Ontario, Canada

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North York, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, 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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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Aalborg, , Denmark

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Blegdamsvej 9, , Denmark

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Farsø, , Denmark

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Gentofte Municipality, , Denmark

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Hillerød, , Denmark

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Hvidovre, , Denmark

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Køge, , Denmark

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Annonay, , France

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Besançon, , France

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Bondy, , France

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Colmar, , France

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Corbeil-Essonnes, , France

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Corsept, , France

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Creil, , France

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Grenoble, , France

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La Chapelle-sur-Erdre, , France

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Nantes, , France

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Paris, , France

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Pessac, , France

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Quimper, , France

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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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Győr, , Hungary

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Gyula, , Hungary

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Hodmeztvasarhely, , Hungary

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Kecskemét, , Hungary

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Keszthely, , Hungary

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Miskolc, , Hungary

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Mosonmagyaróvár, , Hungary

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Nyíregyháza, , Hungary

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Székesfehérvár, , Hungary

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Szolnok, , Hungary

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Tatabánya, , Hungary

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Zalaegerszeg, , Hungary

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Acireale, CT, Italy

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Florence, FI, Italy

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Roma, RM, Italy

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Sottomarnia Di Chioggia, VE, Italy

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Bergamo, , Italy

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Cagliari, , Italy

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Milan, , Italy

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San Giovanni Rotondo, , Italy

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Sassari, , Italy

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Treviglio, , Italy

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Aguascalientes, , Mexico

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Cauntla, , Mexico

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Distrito Federal, , Mexico

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Durango, , Mexico

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Guadalajara, , Mexico

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Saltillo, , Mexico

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San Luis Potosí City, , Mexico

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Zapopan, , Mexico

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Baia Mare, , Romania

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Brasov, , Romania

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Bucharest, , Romania

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Craiova, , Romania

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Lasi, , Romania

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Târgu Mureş, , Romania

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Timișoara, , Romania

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Countries

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United States Argentina Brazil Bulgaria Canada Denmark France Hungary Italy Mexico Romania

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 1

Identifier Type: -

Identifier Source: secondary_id

D3569C00007

Identifier Type: -

Identifier Source: org_study_id

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