AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)

Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240331
• Other study ID #: 4522IL/0096
• Secondary ID: D3562C00096
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2005
• Last updated: May 17, 2011
• Start date: January 2003
• Est. completion date: October 2008

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2776
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• 10mg Rosuvastatin

• Placebo

Locations

Country	Name	City	State
Australia	Research Site	Herston	Queensland
Australia	Research Site	St Leonards	New South Wales
Austria	Research Site	Bregenz
Austria	Research Site	Feldkirch-Tisis
Austria	Research Site	Graz
Austria	Research Site	Innsbruck
Austria	Research Site	Linz
Austria	Research Site	St. Poelten
Austria	Research Site	Wels
Austria	Research Site	Wien
Belgium	Research Site	Aalst
Belgium	Research Site	Antwerpen
Belgium	Research Site	Brussels
Belgium	Research Site	La Louviere
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Brazil	Research Site	Curitiba	PR
Brazil	Research Site	Sao Paulo	SP
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Kitchener
Canada	Research Site	Laval	Quebec
Canada	Research Site	Lethbridge	Alberta
Canada	Research Site	London	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Rosemount
Canada	Research Site	Saint John	New Brunswick
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Trois-Rivieres	Quebec
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Winnipeg	Manitoba
Canada	Research Site	York	Ontario
Czech Republic	Research Site	Hodonin
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Liberec
Czech Republic	Research Site	Pardubice
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Praha 4
Czech Republic	Research Site	Praha 6
Czech Republic	Research Site	Tabor
Czech Republic	Research Site	Usti nad Labem
Denmark	Research Site	Fredericia
Denmark	Research Site	Frederiksberg
Denmark	Research Site	Herlev
Denmark	Research Site	Holbaek
Denmark	Research Site	Horsens
Denmark	Research Site	København Ø
Denmark	Research Site	Rønne
Denmark	Research Site	Roskilde
Denmark	Research Site	Slagelse
Denmark	Research Site	Sønderborg
Denmark	Research Site	Viborg
Finland	Research Site	Helsinki
Finland	Research Site	Hyvinkaa
Finland	Research Site	Joensuu
Finland	Research Site	Kotka
Finland	Research Site	Kuopio
Finland	Research Site	Lahti
Finland	Research Site	Oulu
Finland	Research Site	Pori
Finland	Research Site	Tammisaari
Finland	Research Site	Tampere
Finland	Research Site	Turku
France	Research Site	Amiens
France	Research Site	Annonay Cedex
France	Research Site	Aubervilliers
France	Research Site	Beauvais
France	Research Site	Bethune Cedex
France	Research Site	Boulogne Sur Mer
France	Research Site	Chambery
France	Research Site	Champigny Sur Marne
France	Research Site	Colmar Cedex
France	Research Site	Creil Cedex 1
France	Research Site	Evreux Cedex
France	Research Site	Fleury Merogis
France	Research Site	Foix Cedex
France	Research Site	Le Kremlin-Bicetre
France	Research Site	Maubeuge
France	Research Site	Meaux
France	Research Site	Mont de Marsan Cedex
France	Research Site	Montbonnot Saint Martin
France	Research Site	Nimes
France	Research Site	Olivet
France	Research Site	Paris
France	Research Site	Quimper Cedex
France	Research Site	Saint Maurice
France	Research Site	Saint Michel
France	Research Site	Tournan En Brie
France	Research Site	Valenciennes Cedex
France	Research Site	Vandoeuvre Les Nancy
France	Research Site	Vichy
Germany	Research Site	Ansbach
Germany	Research Site	Aschaffenburg
Germany	Research Site	Bad Münder
Germany	Research Site	Berlin
Germany	Research Site	Bischofswerda
Germany	Research Site	Dresden
Germany	Research Site	Duisburg
Germany	Research Site	Düsseldorf
Germany	Research Site	Erlangen
Germany	Research Site	Frankfurt
Germany	Research Site	Freiburg
Germany	Research Site	Greifswald
Germany	Research Site	Hann Münden
Germany	Research Site	Ingolstadt
Germany	Research Site	Jena
Germany	Research Site	Kaufbeuren
Germany	Research Site	Luedenscheid
Germany	Research Site	Marktheidenfeld
Germany	Research Site	München
Germany	Research Site	Pfarrkirchen
Germany	Research Site	Pirmasens
Germany	Research Site	Regensburg
Germany	Research Site	Rostock
Germany	Research Site	Saarbrucken
Germany	Research Site	Tangermünde
Germany	Research Site	Waldshut
Greece	Research Site	Alexandroupoli
Greece	Research Site	Athens
Greece	Research Site	Ioannina
Greece	Research Site	Thessaloniki
Greece	Research Site	Veroia
Hungary	Research Site	Budapest
Hungary	Research Site	Gyor
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Szeged
Hungary	Research Site	Székesfehérvár
Hungary	Research Site	Veszprém
Iceland	Research Site	Reykjavik
Ireland	Research Site	Galway
Italy	Research Site	Bergamo	BG
Italy	Research Site	Busto Arsizio	VA
Italy	Research Site	Cremona	CR
Italy	Research Site	Genova	GE
Italy	Research Site	Lodi	LO
Italy	Research Site	Milano	Mi
Italy	Research Site	Reggio Calabria	RC
Italy	Research Site	Rozzano	MI
Italy	Research Site	Treviglio	BG
Korea, Republic of	Research Site	Seongnam-Si	Korea
Korea, Republic of	Research Site	Seoul	Korea
Mexico	Research Site	Acapulco	Guerrero
Mexico	Research Site	Cuernavaca	Morelos
Mexico	Research Site	Distrito Federal
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Mexico	D.f.
Mexico	Research Site	Monterrey	Nuevo Leon
Mexico	Research Site	San Luis Potosi
Netherlands	Research Site	Alkmaar
Netherlands	Research Site	Almelo
Netherlands	Research Site	Amersfoort
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Arnhem
Netherlands	Research Site	Den Bosch
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Deventer
Netherlands	Research Site	Dordrecht
Netherlands	Research Site	Emmen
Netherlands	Research Site	Groningen
Netherlands	Research Site	Leeuwarden
Netherlands	Research Site	Nieuwegein
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Sittard
Netherlands	Research Site	Tilburg
Norway	Research Site	Bergen
Norway	Research Site	Drammen
Norway	Research Site	Fredrikstad
Norway	Research Site	Lillehammer
Norway	Research Site	Lorenskog
Norway	Research Site	Oslo
Norway	Research Site	Skien
Norway	Research Site	Stavanger
Norway	Research Site	Tønsberg
Norway	Research Site	Trondheim
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Katowice
Poland	Research Site	Kraków
Poland	Research Site	Lublin
Poland	Research Site	Opole
Poland	Research Site	Plock
Poland	Research Site	Rybnik
Poland	Research Site	Wloclawek
Sweden	Research Site	Eksjö
Sweden	Research Site	Eskilstuna
Sweden	Research Site	Falun
Sweden	Research Site	Gävle
Sweden	Research Site	Göteborg
Sweden	Research Site	Jönköping
Sweden	Research Site	Karlstad
Sweden	Research Site	Linköping
Sweden	Research Site	Lund
Sweden	Research Site	Mölndal
Sweden	Research Site	Norrköping
Sweden	Research Site	Örebro
Sweden	Research Site	Skövde
Sweden	Research Site	Stockholm
Sweden	Research Site	Trollhättan
Sweden	Research Site	Uppsala
Switzerland	Research Site	Aarau
Switzerland	Research Site	Bern
Switzerland	Research Site	Geneve
Switzerland	Research Site	Lausanne
Switzerland	Research Site	St. Gallen
Switzerland	Research Site	Zürich
Turkey	Research Site	Ankara	Besevler
Turkey	Research Site	Antalya	Arapsuyu
Turkey	Research Site	Bursa	Gorukle
Turkey	Research Site	Cebeci	Ankara
Turkey	Research Site	Istanbul	Haydarpasa
Turkey	Research Site	Istanbul	Altunizade
Turkey	Research Site	Izmir	Bornova
Turkey	Research Site	Kampus	Antalya
United Kingdom	Research Site	Antrim	Northern Ireland
United Kingdom	Research Site	Belfast	Northern Ireland
United Kingdom	Research Site	Bradford
United Kingdom	Research Site	Dumfries
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Hull
United Kingdom	Research Site	Kilmarnock
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Middlesborough
United Kingdom	Research Site	Newcastle
United Kingdom	Research Site	Newry	Northern Ireland
United Kingdom	Research Site	Omagh	Northern Ireland
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Rhyl
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Iceland,  Ireland,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Poland,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)		Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years	No
Secondary	Number of Randomised Participants That Died From Any Cause.		Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years	No
Secondary	Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause		Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years	No
Secondary	Number of Randomised Participants That Died From Cardiovascular Cause		Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years	No
Secondary	Number of Randomised Participants That Died From Non Cardiovascular Cause		Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years	No
Secondary	Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)		Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years	No
Secondary	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.		Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years	No
Secondary	Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).		Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years	No