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Completed

NCT Number: NCT00240331

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

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.

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Key information

Conditions

Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, St Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10mg Rosuvastatin

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Oct 18, 2005
Registry last updated
May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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