Clinical trial NCT00296374: Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease
Official title: Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Keywords: Hyperlipidemia
Proteinuria
Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-02-27
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* hyperlipidemia
* urinary protein
* diabetes

Exclusion Criteria:

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

Primary outcomes:
measure: Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.
timeFrame: Assessed at Week 52, Last observation carried forward (LOCF)
Secondary outcomes:
measure: Urinary Protein/Creatinine Ratio at Week 26.
timeFrame: Assessed at Week 26
measure: Urinary Albumin/Creatinine Ratio at Week 26
timeFrame: Assessed at Week 26
measure: Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
timeFrame: Assessed at Week 52 LOCF
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26
timeFrame: Assessed at Baseline and Week 26
measure: Change From Baseline in eGFR at Week 52 [LOCF]
timeFrame: Assessed at Baseline and Week 52 [LOCF]
measure: Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes
timeFrame: 52 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC
timeFrame: Assessed at 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and TC
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and TC
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
timeFrame: 52 Weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
timeFrame: 52 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and TG
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and TG
timeFrame: 52 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
timeFrame: 52 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
timeFrame: 52 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
timeFrame: 52 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
timeFrame: 52 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
timeFrame: 52 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
timeFrame: 26 weeks
measure: Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Avondale
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Jonesboro
country: United States
facility: Research Site
state: Arkansas
city: Pasadena
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facility: Research Site
state: California
city: Riverside
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state: California
city: Santa Ana
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facility: Research Site
state: California
city: West Hills
country: United States
facility: Research Site
state: California
city: Hollywood
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facility: Research Site
state: Florida
city: Jacksonville
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state: Florida
city: West Palm Beach
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facility: Research Site
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city: Augusta
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facility: Research Site
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city: Topeka
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facility: Research Site
state: Kansas
city: Springfield
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facility: Research Site
state: Massachusetts
city: Detroit
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facility: Research Site
state: Michigan
city: Columbia
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facility: Research Site
state: Missouri
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Orchard Park
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facility: Research Site
state: New York
city: Stony Brook
country: United States
facility: Research Site
state: New York
city: Winston Salem
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facility: Research Site
state: North Carolina
city: Cincinnati
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facility: Research Site
state: Ohio
city: Kettering
country: United States
facility: Research Site
state: Ohio
city: Pittsburg
country: United States
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state: Pennsylvania
city: Columbia
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state: South Carolina
city: Dallas
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facility: Research Site
state: Texas
city: Houston
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state: Texas
city: Lubbock
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facility: Research Site
state: Texas
city: San Antonio
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facility: Research Site
state: Texas
city: Ogden
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facility: Research Site
state: Utah
city: Milwaukee
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facility: Research Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Research Site
city: La Plata
country: Argentina
facility: Reasearch Site
city: Moron
country: Argentina
facility: Research Site
city: Quilmes
country: Argentina
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
city: Goiania
country: Brazil
facility: Research Site
city: Recife
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Burgas
country: Bulgaria
facility: Research Site
city: Gabrovo
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Courtice
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state: Ontario
city: North York
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state: Ontario
city: Oshawa
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state: Ontario
city: Ottawa
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state: Ontario
city: Richmond Hill
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state: Ontario
city: Scarborough
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state: Ontario
city: Thunder Bay
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state: Ontario
city: Greenfield Park
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state: Quebec
city: Montreal
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state: Quebec
city: Aalborg
country: Denmark
facility: Research Site
city: Blegdamsvej 9
country: Denmark
facility: Research Site
city: Farso
country: Denmark
facility: Research Site
city: Gentofte
country: Denmark
facility: Research Site
city: Hillerod
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Koge
country: Denmark
facility: Research Site
city: Annonay
country: France
facility: Research Site
city: Besançon
country: France
facility: Research Site
city: Bondy
country: France
facility: Research Site
city: Colmar
country: France
facility: Research Site
city: Corbeil Essonnes
country: France
facility: Research Site
city: Corsept
country: France
facility: Research Site
city: Creil Cedex
country: France
facility: Research Site
city: Grenoble Cedex
country: France
facility: Research Site
city: La Chapelle Sur Erdre
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pessac
country: France
facility: Research Site
city: Quimper
country: France
facility: Research Site
city: Baja
country: Hungary
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research site
city: Hodmeztvasarhely
country: Hungary
facility: Research Site
city: Kecskemét
country: Hungary
facility: Research Site
city: Keszthely
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Mosonmagyarovar
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Tatabanya
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Acireale
country: Italy
facility: Research Site
state: CT
city: Firenze
country: Italy
facility: Research Site
state: FI
city: Roma
country: Italy
facility: Research Site
state: RM
city: Sottomarnia Di Chioggia
country: Italy
facility: Research Site
state: VE
city: Bergamo
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: San Giovanni Rotondo
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Treviglio
country: Italy
facility: Research Site
city: Aguascalientes
country: Mexico
facility: Research Site
city: Cauntla
country: Mexico
facility: Research Site
city: Distrito Federal
country: Mexico
facility: Research Site
city: Durango
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Saltillo
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
city: Zapopan
country: Mexico
facility: Research Site
city: Baia Mare
country: Romania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Lasi
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Crestor Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.