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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00240331
Registration number
NCT00240331
Ethics application status
Date submitted
16/10/2005
Date registered
18/10/2005
Date last updated
19/05/2011
Titles & IDs
Public title
AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
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Scientific 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
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Secondary ID [1]
0
0
D3562C00096
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Secondary ID [2]
0
0
4522IL/0096
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Failure
0
0
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Condition category
Condition code
Renal and Urogenital
0
0
0
0
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Rosuvastatin 10mg -
Placebo comparator: Placebo - matching Placebo
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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0
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
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Assessment method [1]
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0
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Timepoint [1]
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0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
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Secondary outcome [1]
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0
Number of Randomised Participants That Died From Any Cause.
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Assessment method [1]
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0
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Timepoint [1]
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0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
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Secondary outcome [2]
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0
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause
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Assessment method [2]
0
0
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Timepoint [2]
0
0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
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Secondary outcome [3]
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0
Number of Randomised Participants That Died From Cardiovascular Cause
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Assessment method [3]
0
0
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Timepoint [3]
0
0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
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Secondary outcome [4]
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0
Number of Randomised Participants That Died From Non Cardiovascular Cause
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Assessment method [4]
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0
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Timepoint [4]
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0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
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Secondary outcome [5]
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0
Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)
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Assessment method [5]
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0
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Timepoint [5]
0
0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
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Secondary outcome [6]
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0
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.
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Assessment method [6]
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0
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Timepoint [6]
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Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
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Secondary outcome [7]
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Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).
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Assessment method [7]
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Timepoint [7]
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Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
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Eligibility
Key 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
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Minimum age
50
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2008
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Sample size
Target
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Accrual to date
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Final
2776
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Research Site - St Leonards
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Recruitment hospital [2]
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Research Site - Herston
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Recruitment postcode(s) [1]
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- St Leonards
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Recruitment postcode(s) [2]
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- Herston
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Recruitment outside Australia
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Austria
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Bregenz
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Austria
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Feldkirch-Tisis
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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St. Poelten
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Austria
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Montbonnot Saint Martin
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Mexico
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D.f.
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Mexico
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Distrito Federal
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Mexico
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San Luis Potosi
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Emmen
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Tilburg
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Norway
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Bergen
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Drammen
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Skien
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Rybnik
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Stockholm
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Uppsala
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Örebro
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Bern
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Geneve
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Lausanne
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Turkey
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Bornova
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United Kingdom
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Northern Ireland
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Bradford
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Glasgow
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Hull
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Leeds
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London
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Manchester
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Newcastle
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Rhyl
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Sheffield
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United Kingdom
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Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00240331
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Trial related presentations / 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. Erratum In: N Engl J Med. 2010 Apr 15;362(15):1450.
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Public notes
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Contacts
Principal investigator
Name
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AstraZeneca Crestor Medical Sciences Director, MD
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Address
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AstraZeneca
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00240331
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