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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Failure | Drug: 10mg Rosuvastatin Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2776 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Rosuvastatin 10mg |
Drug: 10mg Rosuvastatin |
Placebo Comparator: Placebo
matching Placebo
|
Drug: Placebo |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240331

Study Director: | AstraZeneca Crestor Medical Sciences Director, MD | AstraZeneca |
Responsible Party: | MSD, AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00240331 |
Other Study ID Numbers: |
4522IL/0096 D3562C00096 |
First Posted: | October 18, 2005 Key Record Dates |
Results First Posted: | November 4, 2009 |
Last Update Posted: | May 19, 2011 |
Last Verified: | May 2011 |
End Stage Renal Failure |
Renal Insufficiency Kidney Diseases Urologic Diseases Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |