Clinical trial NCT00296400: Prospective Evaluation of Proteinuria and Renal Function in Non-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 Non-diabetic Patients With Moderate Proteinuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperlipidemia
Keywords: Hyperlipidemia
Proteinuria
Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-02-27
Enrollment: 237
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 non-diabetes with moderate proteinuria and hypercholesterolaemia.


Eligibility criteria: 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

Primary outcomes:
measure: Urinary Protein/Creatinine Ratio at Week 52 [LOCF]
timeFrame: Assessed at baseline and Week 52 (LOCF)
Secondary outcomes:
measure: Urinary Protein/Creatinine Ratio at Week 26.
timeFrame: Assessed at baseline and Week 26
measure: Urinary Albumin/Creatinine Ratio at Week 26
timeFrame: Assessed at baseline and Week 26
measure: Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
timeFrame: Assessed at baseline and 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 of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26.
timeFrame: baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52.
timeFrame: 52 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C
timeFrame: 52 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in High Density Lipoprotein Cholesterol [HDL-C] at Week 26
timeFrame: 26 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol [nonHDL-C] at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52
timeFrame: 52 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG
timeFrame: Baseline and 52 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52
timeFrame: Baseline and 52 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26
timeFrame: Baseline and 26 weeks
measure: Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52
timeFrame: Baseline and 52 weeks
Other outcomes:
Locations:
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facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Pasadena
country: United States
facility: Research Site
state: California
city: Riverside
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facility: Research Site
state: California
city: Clearwater
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state: Florida
city: Hollywood
country: United States
facility: Research Site
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city: Jacksonville
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city: Detroit
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city: Winston Salem
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state: North Carolina
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city: Pittsburgh
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state: Pennsylvania
city: Columbia
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city: Houston
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state: Texas
city: San Antonio
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state: Texas
city: Richmond
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facility: Research Site
state: Virginia
city: Gig Harbor
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state: Washington
city: Milwaukee
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state: Wisconsin
city: Curitiba
country: Brazil
facility: Research Site
state: PR
city: Sao Paulo
country: Brazil
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state: SP
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Burgas
country: Bulgaria
facility: Research Site
city: Gabrovo
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
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city: Plovdiv
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city: Sofia
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city: Varna
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facility: Research Site
city: Veliko Turnovo
country: Bulgaria
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: St John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Courtice
country: Canada
facility: Research Site
state: Ontario
city: East York
country: Canada
facility: Research Site
state: Ontario
city: Oakville
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state: Ontario
city: Oshawa
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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: Quebec
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country: Denmark
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country: Denmark
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city: Gy�r
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city: Keszthely
country: Hungary
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city: Miskolc
country: Hungary
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city: Nyiregyhaza
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facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
state: BG
city: Bologna
country: Italy
facility: Research Site
state: BO
city: Brescia
country: Italy
facility: Research Site
state: BS
city: Acireale
country: Italy
facility: Research Site
state: CT
city: Foggia
country: Italy
facility: Research Site
state: FG
city: Firenze
country: Italy
facility: Research Site
state: FI
city: Parma
country: Italy
facility: Research Site
state: PR
city: Reggio Calabria
country: Italy
facility: Research Site
state: RC
city: Sassari
country: Italy
facility: Research Site
state: SS
city: Teramo
country: Italy
facility: Research Site
state: TE
city: Torino
country: Italy
facility: Research Site
state: TO
city: Castelfranco Veneto
country: Italy
facility: Research Site
state: TV
city: Treviso
country: Italy
facility: Research Site
state: TV
city: Mestre
country: Italy
facility: Research Site
state: VE
city: Mexico
country: Mexico
facility: Research Site
state: DF
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Research Site
state: Morelos
city: Aguascalientes
country: Mexico
facility: Research Site
city: D.F
country: Mexico
facility: Research Site
city: Durango
country: Mexico
facility: Research Site
city: San Luis Potos�
country: Mexico
facility: Research Site
city: Cluj Napoca
country: Romania
facility: Research Site
state: Cluj
city: Timisoara
country: Romania
facility: Research Site
state: Timis
city: Brasov
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Suceava
country: Romania
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
state: Gauteng
city: Parow
country: South Africa
facility: Research Site
state: W Cape
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
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.