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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Failure Drug: 10mg Rosuvastatin Drug: Placebo Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rosuvastatin 10mg Drug: 10mg Rosuvastatin
Placebo Comparator: Placebo
matching Placebo
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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. 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. 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 ]

Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Crestor Medical Sciences Director, MD AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by AstraZeneca:
End Stage Renal Failure
Additional relevant MeSH terms:
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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