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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
History of Changes
  Purpose

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 Intervention Phase
Renal Failure
 Drug: 10mg Rosuvastatin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2776
Study Start Date: January 2003
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin 10mg Drug: 10mg Rosuvastatin
Placebo Comparator: Placebo
matching Placebo
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240331

  Show 241 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Crestor Medical Sciences Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional 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

Keywords provided by AstraZeneca:
End Stage Renal Failure

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013