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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
Country [1] 0 0
Austria
State/province [1] 0 0
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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Linz
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St. Poelten
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Wels
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Wien
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Belgium
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Aalst
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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La Louviere
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Belgium
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Leuven
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Liège
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PR
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Brazil
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SP
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Pleven
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Sofia
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Nova Scotia
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Hull
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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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Crestor Medical Sciences Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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