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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00240331
First received: October 16, 2005
Last updated: May 17, 2011
Last verified: May 2011
Results First Received: September 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Prevention
Condition: Renal Failure
Interventions: Drug: 10mg Rosuvastatin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited patients were male or female with end-stage renal failure aged 50 to 80 years, who had received regular chronic haemodialysis treatment (including haemofiltration and hemodiafiltration ) for at least 3 months. They were recruited from 280 sites in 25 countries; recruitment started on 16 January 2003 and finished on 24 November 2004.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a two week screening period, eligible patients were randomly assigned to either rosuvastatin treatment (10mg/day) or placebo with a 1:1 randomisation ratio. Follow-up was planned to continue until the accrual of 805 major cardiovascular events

Reporting Groups
  Description
Rosuvastatin 10mg Rosuvastatin 10 mg oral tablets
Placebo Matching placebo

Participant Flow:   Overall Study
    Rosuvastatin 10mg   Placebo
STARTED   1389 [1]   1384 [2] 
COMPLETED   1263 [3]   1250 [3] 
NOT COMPLETED   126   134 
Withdrawal by Subject                125                132 
Option selected by investigator                1                2 
[1] Two patients were incorrectly randomised and not included in the analyses.
[2] One patient was incorrectly randomised and not included in the analyses
[3] Vital status was obtained for all randomised patients at the end of the study



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rosuvastatin 10mg Rosuvastatin 10 mg oral tablets
Placebo Matching placebo
Total Total of all reporting groups

Baseline Measures
   Rosuvastatin 10mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1389   1384   2773 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.1  (8.6)   64.3  (8.7)   64.2  (8.6) 
Gender 
[Units: Participants]
     
Female   538   512   1050 
Male   851   872   1723 


  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  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.   [ Time Frame: Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The endpoints were originally intended to be time to event endpoints, however we are unable to report the data as intended due to the nature of time to event endpoints. Therefore we have reported the number of participants who reached the event.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00240331     History of Changes
Other Study ID Numbers: 4522IL/0096
D3562C00096
Study First Received: October 16, 2005
Results First Received: September 29, 2009
Last Updated: May 17, 2011
Health Authority: Sweden: Medical Products Agency