AURORA: Crestor 10mg vs Placebo in Subjects With ESRD

Condition(s) targeted: End Stage Renal Failure

Intervention: 10mg Rosuvastatin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Crestor Medical Sciences Director, MD, Study Director, Affiliation: AstraZeneca

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.

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 design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Assessment of time to major cardiovascular event (combined endpoint of non-fatal stroke, non-fatal myocardial infarction or cardiovascular death).

Secondary outcome:

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

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Both.

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

Research Site, Bregenz, Austria

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Starting date: July 2004
Last updated: October 5, 2006