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

May 17, 2011 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2776

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia
        • Research Site
    • Queensland
      • Herston, Queensland, Australia
        • Research Site
  • Austria
      • 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, Austria
        • Research Site
  • Belgium
      • Aalst, Belgium
        • Research Site
      • Antwerpen, Belgium
        • Research Site
      • Brussels, Belgium
        • Research Site
      • La Louviere, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
      • Liège, Belgium
        • Research Site
  • Brazil
    • PR
      • Curitiba, PR, Brazil
        • Research Site
    • SP
      • Sao Paulo, SP, Brazil
        • Research Site
  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Canada
      • Kitchener, Canada
        • Research Site
      • Rosemount, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
      • Lethbridge, Alberta, Canada
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Research Site
      • Vancouver, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • London, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
      • Scarborough, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • York, Ontario, Canada
        • Research Site
    • Quebec
      • Greenfield Park, Quebec, Canada
        • Research Site
      • Laval, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
      • Trois-Rivieres, Quebec, Canada
        • Research Site
  • Czech Republic
      • 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, Czech Republic
        • Research Site
  • Denmark
      • 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
      • Roskilde, Denmark
        • Research Site
      • Rønne, Denmark
        • Research Site
      • Slagelse, Denmark
        • Research Site
      • Sønderborg, Denmark
        • Research Site
      • Viborg, Denmark
        • Research Site
  • Finland
      • 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, Finland
        • Research Site
  • France
      • 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, France
        • Research Site
  • Germany
      • 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, Germany
        • Research Site
  • Greece
      • Alexandroupoli, Greece
        • Research Site
      • Athens, Greece
        • Research Site
      • Ioannina, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
      • Veroia, Greece
        • Research Site
  • Hungary
      • 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, Hungary
        • Research Site
  • Iceland
      • Reykjavik, Iceland
        • Research Site
  • Ireland
      • Galway, Ireland
        • Research Site
  • Italy
    • BG
      • Bergamo, BG, Italy
        • Research Site
      • Treviglio, BG, Italy
        • Research Site
    • CR
      • Cremona, CR, Italy
        • Research Site
    • GE
      • Genova, GE, Italy
        • Research Site
    • LO
      • Lodi, LO, Italy
        • Research Site
    • MI
      • Rozzano, MI, Italy
        • Research Site
    • Mi
      • Milano, Mi, Italy
        • Research Site
    • RC
      • Reggio Calabria, RC, Italy
        • Research Site
    • VA
      • Busto Arsizio, VA, Italy
        • Research Site
  • Korea, Republic of
    • Korea
      • Seongnam-Si, Korea, Korea, Republic of
        • Research Site
      • Seoul, Korea, Korea, Republic of
        • Research Site
  • Mexico
      • Distrito Federal, Mexico
        • Research Site
      • San Luis Potosi, Mexico
        • Research Site
    • D.f.
      • Mexico, D.f., Mexico
        • Research Site
    • Guerrero
      • Acapulco, Guerrero, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • Research Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Research Site
  • Netherlands
      • 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, Netherlands
        • Research Site
  • Norway
      • 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
      • Trondheim, Norway
        • Research Site
      • Tønsberg, Norway
        • Research Site
  • Poland
      • 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, Poland
        • Research Site
  • Sweden
      • 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
      • Skövde, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Trollhättan, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
      • Örebro, Sweden
        • Research Site
  • Switzerland
      • Aarau, Switzerland
        • Research Site
      • Bern, Switzerland
        • Research Site
      • Geneve, Switzerland
        • Research Site
      • Lausanne, Switzerland
        • Research Site
      • St. Gallen, Switzerland
        • Research Site
      • Zürich, Switzerland
        • Research Site
  • Turkey
    • Altunizade
      • Istanbul, Altunizade, Turkey
        • Research Site
    • Ankara
      • Cebeci, Ankara, Turkey
        • Research Site
    • Antalya
      • Kampus, Antalya, Turkey
        • Research Site
    • Arapsuyu
      • Antalya, Arapsuyu, Turkey
        • Research Site
    • Besevler
      • Ankara, Besevler, Turkey
        • Research Site
    • Bornova
      • Izmir, Bornova, Turkey
        • Research Site
    • Gorukle
      • Bursa, Gorukle, Turkey
        • Research Site
    • Haydarpasa
      • Istanbul, Haydarpasa, Turkey
        • Research Site
  • United Kingdom
      • 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
      • Plymouth, United Kingdom
        • Research Site
      • Rhyl, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Surrey, United Kingdom
        • Research Site
    • Northern Ireland
      • Antrim, Northern Ireland, United Kingdom
        • Research Site
      • Belfast, Northern Ireland, United Kingdom
        • Research Site
      • Newry, Northern Ireland, United Kingdom
        • Research Site
      • Omagh, Northern Ireland, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosuvastatin 10mg
Drug: 10mg Rosuvastatin
Placebo Comparator: Placebo
matching Placebo
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Crestor Medical Sciences Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

October 16, 2005

First Submitted That Met QC Criteria

October 16, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4522IL/0096
  • D3562C00096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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