Renal FailurePhase 3NCT00240331
AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
A Phase 3 study testing 10mg Rosuvastatin in people with Renal Failure, run by AstraZeneca at 239 sites in 25 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- 10mg Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,776 participants
- Where
- 239 sitesin 25 countries
- Study dates
- Jan 2003to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects with end-stage renal failure aged 50-80 years, who have received regular haemodialysis treatment for at least 3 months
Who cannot join
- 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
Trial locations and contacts
239 sites in 25 countries.
239 sites in 25 countries
France28 sites
Research Site
Amiens
Research Site
Annonay
Research Site
Aubervilliers
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Beauvais
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Béthune
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Boulogne-sur-Mer
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Chambéry
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Champigny-sur-Marne
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Colmar
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Creil
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Évreux
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Fleury-Mérogis
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Foix
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Le Kremlin-Bicêtre
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Maubeuge
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Meaux
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Mont-de-Marsan
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Montbonnot-Saint-Martin
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Nîmes
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Olivet
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Paris
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Quimper
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Saint-Maurice
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Saint-Michel
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Tournan-en-Brie
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Valenciennes
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Vandœuvre-lès-Nancy
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Vichy
Germany26 sites
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Ansbach
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Aschaffenburg
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Bad Münder am Deister
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Berlin
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Bischofswerda
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Dresden
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Duisburg
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Düsseldorf
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Erlangen
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Frankfurt
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Freiburg im Breisgau
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Greifswald
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Hannoversch Münden
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Ingolstadt
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Jena
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Kaufbeuren
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Lüdenscheid
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Marktheidenfeld
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München
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Pfarrkirchen
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Pirmasens
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Regensburg
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Rostock
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Saarbrücken
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Tangermünde
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Waldshut
Canada19 sites
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Calgary, Alberta
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Edmonton, Alberta
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Greenfield Park, Quebec
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Halifax, Nova Scotia
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Kelowna, British Columbia
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Kitchener
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Laval, Quebec
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Lethbridge, Alberta
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London, Ontario
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Mississauga, Ontario
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Montreal, Quebec
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Rosemount
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Saint John, New Brunswick
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Scarborough Village, Ontario
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Toronto, Ontario
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Trois-Rivières, Quebec
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Vancouver, British Columbia
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Winnipeg, Manitoba
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York, Ontario
United Kingdom19 sites
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Antrim, Northern Ireland
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Belfast, Northern Ireland
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Bradford
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Dumfries
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Dundee
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Glasgow
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Hull
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Kilmarnock
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Leeds
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London
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Manchester
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Middlesbrough
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Newcastle
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Newry, Northern Ireland
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Omagh, Northern Ireland
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Plymouth
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Rhyl
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Sheffield
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Surrey
Netherlands16 sites
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's-Hertogenbosch
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Alkmaar
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Almelo
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Amersfoort
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Amsterdam
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Arnhem
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Deventer
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Dordrecht
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Emmen
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Groningen
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Leeuwarden
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Nieuwegein
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Rotterdam
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Sittard
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The Hague
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Tilburg
Sweden16 sites
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Eksjö
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Eskilstuna
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Falun
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Gävle
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Gothenburg
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Jönköping
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Karlstad
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Linköping
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Lund
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Mölndal
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Norrköping
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Örebro
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Skövde
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Stockholm
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Trollhättan
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Uppsala
Denmark11 sites
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Fredericia
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Frederiksberg
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Herlev
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Holbæk
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Horsens
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København Ø
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Rønne
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Roskilde
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Slagelse
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Sønderborg
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Viborg
Finland11 sites
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Ekenäs
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Helsinki
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Hyvinkää
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Joensuu
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Kotka
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Kuopio
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Lahti
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Oulu
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Pori
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Tampere
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Turku
Norway10 sites
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Bergen
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Drammen
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Fredrikstad
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Lillehammer
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Lorenskog
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Oslo
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Skien
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Stavanger
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Tønsberg
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Trondheim
Italy9 sites
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Bergamo, BG
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Busto Arsizio, VA
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Cremona, CR
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Genova, GE
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Lodi, LO
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Milan, Mi
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Reggio Calabria, RC
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Rozzano, MI
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Treviglio, BG
Poland9 sites
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Bialystok
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Gdansk
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Katowice
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Krakow
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Lublin
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Opole
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Płock
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Rybnik
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Włocławek
Austria8 sites
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Bregenz
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Feldkirch-Tisis
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Graz
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Innsbruck
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Linz
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Sankt Pölten
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Vienna
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Wels
Turkey (Türkiye)8 sites
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Ankara, Besevler
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Antalya, Arapsuyu
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Bursa, Gorukle
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Cebeci, Ankara
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Istanbul, Altunizade
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Istanbul, Haydarpasa
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Izmir, Bornova
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Kampus, Antalya
Czechia7 sites
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Hodonín
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Hradec Králové
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Liberec
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Pardubice
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Prague
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Tábor
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Ústí nad Labem
Hungary7 sites
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Budapest
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Győr
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Miskolc
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Nyíregyháza
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Szeged
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Székesfehérvár
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Veszprém
Mexico7 sites
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Acapulco de Juárez, Guerrero
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Cuernavaca, Morelos
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Distrito Federal
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Guadalajara, Jalisco
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México, D.f.
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Monterrey, Nuevo León
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San Luis Potosí City
Belgium6 sites
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Aalst
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Antwerp
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Brussels
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La Louvière
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Leuven
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Liège
Switzerland6 sites
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Aarau
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Bern
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Geneva
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Lausanne
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Sankt Gallen
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Zurich
Greece5 sites
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Alexandroupoli
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Athens
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Ioannina
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Thessaloniki
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Véroia
Australia2 sites
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Herston, Queensland
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St Leonards, New South Wales
South Korea2 sites
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Seongnam-si, Korea
Research Site
Seoul, Korea
About this study
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
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.
- Conditions
- Renal Failure
- Being tested
- 10mg Rosuvastatin, Placebo
- Keywords
- End Stage Renal Failure
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10mg RosuvastatinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 10mg | Experimental | Not described Receives: Drug: 10mg Rosuvastatin |
| Placebo | Placebo comparator | matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
Measured: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Secondary outcomes (7)
Number of Randomised Participants That Died From Any Cause.
Measured: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause
Measured: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Died From Cardiovascular Cause
Measured: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Died From Non Cardiovascular Cause
Measured: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)
Measured: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
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.
Measured: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).
Measured: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startJan 2003
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,776 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Crestor Medical Sciences Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240331
- Sponsor's protocol ID
- 4522IL/0096
- Other IDs
- D3562C00096
- Status last verified
- May 2011
- First submitted
- 16 Oct 2005
- Last updated
- 19 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 19332456
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00240331
- Acronym / sponsor ID
- 4522IL/0096
- Conditions
- Renal Failure
- Keywords
- End Stage Renal Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,776 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 18 Oct 2005 (estimated)
- Results
- Posted 4 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 10mg | Experimental | Drug: 10mg Rosuvastatin |
| Placebo | Placebo comparator | Drug: Placebomatching Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female subjects with end-stage renal failure aged 50-80 years, who have received regular haemodialysis treatment for at least 3 months
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10mg Rosuvastatin | Drug | Rosuvastatin 10mg |
| Placebo | Drug | Placebo |
Primary outcome
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
Time frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
7 secondary outcomes
Number of Randomised Participants That Died From Any Cause.
Time frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause
Time frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Died From Cardiovascular Cause
Time frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Died From Non Cardiovascular Cause
Time frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)
Time frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
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.
Time frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).
Time frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19332456Fellstrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Crestor Medical Sciences Director, MD study director
AstraZeneca
239 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10mg Rosuvastatin in people with Renal Failure, run by AstraZeneca at 239 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 239 sites in France, Germany, Canada, United Kingdom, Netherlands and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death) (time frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00240331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.