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

• 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: AstraZeneca
• Information provided by: AstraZeneca

Tracking Information

• First Submitted Date: October 16, 2005
• First Posted Date: October 18, 2005
• Results First Submitted Date: September 29, 2009
• Results First Posted Date: November 4, 2009
• Last Update Posted Date: May 19, 2011
• Study Start Date: January 2003
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (submitted: October 16, 2005): Assessment of time to major cardiovascular event (combined endpoint of non-fatal stroke, non-fatal myocardial infarction or cardiovascular death).

Current Secondary Outcome Measures (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 (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: AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
• Official 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Prevention
• Condition: Renal Failure

Intervention

• Drug: 10mg Rosuvastatin
• Drug: Placebo

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 29, 2009): 2776
• Original Enrollment (submitted: October 16, 2005): 2700
• Actual Study Completion Date: October 2008
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 50 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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

Administrative Information

• NCT Number: NCT00240331
• Other Study ID Numbers: 4522IL/0096; D3562C00096
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: MSD, AstraZeneca
• Study Sponsor: AstraZeneca
• Collaborators: Not Provided

Investigators

• Study Director: AstraZeneca Crestor Medical Sciences Director, MD; AstraZeneca

• PRS Account: AstraZeneca
• Verification Date: May 2011