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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)
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
Secondary ID [1] 0 0
D3562C00096
Secondary ID [2] 0 0
4522IL/0096
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Rosuvastatin 10mg -

Placebo comparator: Placebo - matching Placebo
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)
Timepoint [1] 0 0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Secondary outcome [1] 0 0
Number of Randomised Participants That Died From Any Cause.
Timepoint [1] 0 0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Secondary outcome [2] 0 0
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause
Timepoint [2] 0 0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Secondary outcome [3] 0 0
Number of Randomised Participants That Died From Cardiovascular Cause
Timepoint [3] 0 0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Secondary outcome [4] 0 0
Number of Randomised Participants That Died From Non Cardiovascular Cause
Timepoint [4] 0 0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Secondary outcome [5] 0 0
Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)
Timepoint [5] 0 0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Secondary outcome [6] 0 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.
Timepoint [6] 0 0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years
Secondary outcome [7] 0 0
Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).
Timepoint [7] 0 0
Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

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
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
2776
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Research Site - St Leonards
Recruitment hospital [2] 0 0
Research Site - Herston
Recruitment postcode(s) [1] 0 0
- St Leonards
Recruitment postcode(s) [2] 0 0
- Herston
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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Linz
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Middlesborough
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Newcastle
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Plymouth
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Rhyl
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Sheffield
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Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00240331
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.
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Crestor Medical Sciences Director, MD
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AstraZeneca
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00240331