Clinical trial NCT00240331: AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
Official title: A Study to Evaluate the Use of Rosuvastatin in Subjects On Regular Haemodialysis: an Assessment of Survival and Cardiovascular Events (AURORA). A Double Blind, Randomised, Phase 3b, Parallel-group Study to Compare the Effects of Rosuvastatin With Placebo on Assessment of Survival & Cardiovascular Events When Given to Subjects With End-stage Renal Failure on Chronic Haemodialysis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Failure
Keywords: End Stage Renal Failure
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 2776
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects with end-stage renal failure aged 50-80 years, who have received regular haemodialysis treatment for at least 3 months

Exclusion Criteria:

* Subjects will have no underlying condition that is expected to limit survival to less than 1 year and is also unrelated to end-stage renal disease (ESRD). Subjects should not have received a statin therapy within the past 6 months

Primary outcomes:
measure: Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
timeFrame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Secondary outcomes:
measure: Number of Randomised Participants That Died From Any Cause.
timeFrame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
measure: Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause
timeFrame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
measure: Number of Randomised Participants That Died From Cardiovascular Cause
timeFrame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
measure: Number of Randomised Participants That Died From Non Cardiovascular Cause
timeFrame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
measure: Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)
timeFrame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
measure: Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis.
timeFrame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
measure: Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).
timeFrame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Research Site
state: New South Wales
city: Herston
country: Australia
facility: Research Site
state: Queensland
city: Bregenz
country: Austria
facility: Research Site
city: Feldkirch-Tisis
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: St. Poelten
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: La Louviere
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
state: PR
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Lethbridge
country: Canada
facility: Research Site
state: Alberta
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
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state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Saint John
country: Canada
facility: Research Site
state: New Brunswick
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: London
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: York
country: Canada
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state: Ontario
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Laval
country: Canada
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state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Trois-Rivieres
country: Canada
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state: Quebec
city: Kitchener
country: Canada
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city: Rosemount
country: Canada
facility: Research Site
city: Hodonin
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Liberec
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha 4
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
facility: Research Site
city: Tabor
country: Czech Republic
facility: Research Site
city: Usti nad Labem
country: Czech Republic
facility: Research Site
city: Fredericia
country: Denmark
facility: Research Site
city: Frederiksberg
country: Denmark
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: Holbaek
country: Denmark
facility: Research Site
city: Horsens
country: Denmark
facility: Research Site
city: København Ø
country: Denmark
facility: Research Site
city: Roskilde
country: Denmark
facility: Research Site
city: Rønne
country: Denmark
facility: Research Site
city: Slagelse
country: Denmark
facility: Research Site
city: Sønderborg
country: Denmark
facility: Research Site
city: Viborg
country: Denmark
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Hyvinkaa
country: Finland
facility: Research Site
city: Joensuu
country: Finland
facility: Research Site
city: Kotka
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Lahti
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Pori
country: Finland
facility: Research Site
city: Tammisaari
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Annonay Cedex
country: France
facility: Research Site
city: Aubervilliers
country: France
facility: Research Site
city: Beauvais
country: France
facility: Research Site
city: Bethune Cedex
country: France
facility: Research Site
city: Boulogne Sur Mer
country: France
facility: Research Site
city: Chambery
country: France
facility: Research Site
city: Champigny Sur Marne
country: France
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city: Colmar Cedex
country: France
facility: Research Site
city: Creil Cedex 1
country: France
facility: Research Site
city: Evreux Cedex
country: France
facility: Research Site
city: Fleury Merogis
country: France
facility: Research Site
city: Foix Cedex
country: France
facility: Research Site
city: Le Kremlin-Bicetre
country: France
facility: Research Site
city: Maubeuge
country: France
facility: Research Site
city: Meaux
country: France
facility: Research Site
city: Mont de Marsan Cedex
country: France
facility: Research Site
city: Montbonnot Saint Martin
country: France
facility: Research Site
city: Nimes
country: France
facility: Research Site
city: Olivet
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Quimper Cedex
country: France
facility: Research Site
city: Saint Maurice
country: France
facility: Research Site
city: Saint Michel
country: France
facility: Research Site
city: Tournan En Brie
country: France
facility: Research Site
city: Valenciennes Cedex
country: France
facility: Research Site
city: Vandoeuvre Les Nancy
country: France
facility: Research Site
city: Vichy
country: France
facility: Research Site
city: Ansbach
country: Germany
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Bad Münder
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bischofswerda
country: Germany
facility: Research Site
city: Dresden
country: Germany
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city: Duisburg
country: Germany
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city: Düsseldorf
country: Germany
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city: Erlangen
country: Germany
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city: Frankfurt
country: Germany
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city: Freiburg
country: Germany
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city: Greifswald
country: Germany
facility: Research Site
city: Hann Münden
country: Germany
facility: Research Site
city: Ingolstadt
country: Germany
facility: Research Site
city: Jena
country: Germany
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city: Kaufbeuren
country: Germany
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city: Luedenscheid
country: Germany
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city: Marktheidenfeld
country: Germany
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city: München
country: Germany
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city: Pfarrkirchen
country: Germany
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city: Pirmasens
country: Germany
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city: Regensburg
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Saarbrucken
country: Germany
facility: Research Site
city: Tangermünde
country: Germany
facility: Research Site
city: Waldshut
country: Germany
facility: Research Site
city: Alexandroupoli
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Veroia
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
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city: Miskolc
country: Hungary
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city: Nyiregyhaza
country: Hungary
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city: Szeged
country: Hungary
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city: Székesfehérvár
country: Hungary
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city: Veszprém
country: Hungary
facility: Research Site
city: Reykjavik
country: Iceland
facility: Research Site
city: Galway
country: Ireland
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
state: BG
city: Treviglio
country: Italy
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state: BG
city: Cremona
country: Italy
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state: CR
city: Genova
country: Italy
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state: GE
city: Lodi
country: Italy
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state: LO
city: Milano
country: Italy
facility: Research Site
state: Mi
city: Rozzano
country: Italy
facility: Research Site
state: MI
city: Reggio Calabria
country: Italy
facility: Research Site
state: RC
city: Busto Arsizio
country: Italy
facility: Research Site
state: VA
city: Seongnam-Si
country: Korea, Republic of
facility: Research Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Korea
city: Mexico
country: Mexico
facility: Research Site
state: D.f.
city: Acapulco
country: Mexico
facility: Research Site
state: Guerrero
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Research Site
state: Morelos
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo Leon
city: Distrito Federal
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
city: Alkmaar
country: Netherlands
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city: Almelo
country: Netherlands
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city: Amersfoort
country: Netherlands
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city: Amsterdam
country: Netherlands
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city: Arnhem
country: Netherlands
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city: Den Bosch
country: Netherlands
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city: Den Haag
country: Netherlands
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city: Emmen
country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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country: Netherlands
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city: Tilburg
country: Netherlands
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city: Bergen
country: Norway
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city: Drammen
country: Norway
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city: Fredrikstad
country: Norway
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city: Lillehammer
country: Norway
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city: Lorenskog
country: Norway
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city: Oslo
country: Norway
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country: Norway
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country: Norway
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city: Trondheim
country: Norway
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city: Tønsberg
country: Norway
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city: Bialystok
country: Poland
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country: Poland
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city: Katowice
country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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city: Wloclawek
country: Poland
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city: Eksjö
country: Sweden
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city: Eskilstuna
country: Sweden
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city: Falun
country: Sweden
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city: Gävle
country: Sweden
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city: Göteborg
country: Sweden
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city: Jönköping
country: Sweden
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city: Karlstad
country: Sweden
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city: Linköping
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Mölndal
country: Sweden
facility: Research Site
city: Norrköping
country: Sweden
facility: Research Site
city: Skövde
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
city: Aarau
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Geneve
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
city: Zürich
country: Switzerland
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
state: Altunizade
city: Cebeci
country: Turkey
facility: Research Site
state: Ankara
city: Kampus
country: Turkey
facility: Research Site
state: Antalya
city: Antalya
country: Turkey
facility: Research Site
state: Arapsuyu
city: Ankara
country: Turkey
facility: Research Site
state: Besevler
city: Izmir
country: Turkey
facility: Research Site
state: Bornova
city: Bursa
country: Turkey
facility: Research Site
state: Gorukle
city: Istanbul
country: Turkey
facility: Research Site
state: Haydarpasa
city: Antrim
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Belfast
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Newry
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Omagh
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Bradford
country: United Kingdom
facility: Research Site
city: Dumfries
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Kilmarnock
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Middlesborough
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Rhyl
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Surrey
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Crestor Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
citation: Fellstrom BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Gronhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Suleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wuthrich RP, Gottlow M, Johnsson E, Zannad F; AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 Apr 2;360(14):1395-407. doi: 10.1056/NEJMoa0810177. Epub 2009 Mar 30.