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

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ClinicalTrials.gov Identifier: NCT00240331
Recruitment Status : Completed
First Posted : October 18, 2005
Results First Posted : November 4, 2009
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 16, 2005
First Posted Date  ICMJE October 18, 2005
Results First Submitted Date  ICMJE September 29, 2009
Results First Posted Date  ICMJE November 4, 2009
Last Update Posted Date May 19, 2011
Study Start Date  ICMJE January 2003
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2005)
Assessment of time to major cardiovascular event (combined endpoint of non-fatal stroke, non-fatal myocardial infarction or cardiovascular death).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2011)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2005)
  • - - To assess the safety of treatment
  • - To determine the cost due to hospitalisations (expressed as cost per life year saved)
  • - To determine the effect of treatment on the % changes in various cholesterol laboratory assessments
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Renal Failure
Intervention  ICMJE
  • Drug: 10mg Rosuvastatin
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Rosuvastatin 10mg
    Intervention: Drug: 10mg Rosuvastatin
  • Placebo Comparator: Placebo
    matching Placebo
    Intervention: Drug: Placebo
Publications * Fellström BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Grönhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Süleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wüthrich 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2009)
2776
Original Enrollment  ICMJE
 (submitted: October 16, 2005)
2700
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Iceland,   Ireland,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Poland,   Sweden,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00240331
Other Study ID Numbers  ICMJE 4522IL/0096
D3562C00096
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MSD, AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Crestor Medical Sciences Director, MD AstraZeneca
PRS Account AstraZeneca
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP