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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00240331

Enrollment

2776

Registered

2005-10-18

Start date

2003-01-31

Completion date

2008-10-31

Last updated

2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure

Keywords

End Stage Renal Failure

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.

Interventions

DRUG10mg Rosuvastatin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)	Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Secondary

Measure	Time frame
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause	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	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	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.	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.	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).	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)	Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years

Countries

Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Mexico, Netherlands, Norway, Poland, South Korea, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Participant flow

Recruitment details

Recruited patients were male or female with end-stage renal failure aged 50 to 80 years, who had received regular chronic haemodialysis treatment (including haemofiltration and hemodiafiltration ) for at least 3 months. They were recruited from 280 sites in 25 countries; recruitment started on 16 January 2003 and finished on 24 November 2004.

Pre-assignment details

After a two week screening period, eligible patients were randomly assigned to either rosuvastatin treatment (10mg/day) or placebo with a 1:1 randomisation ratio. Follow-up was planned to continue until the accrual of 805 major cardiovascular events

Participants by arm

Arm	Count
Rosuvastatin 10mg Rosuvastatin 10 mg oral tablets	1,389
Placebo Matching placebo	1,384
Total	2,773

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Option selected by investigator	1	2
Overall Study	Withdrawal by Subject	125	132

Baseline characteristics

Characteristic	Rosuvastatin 10mg	Placebo	Total
Age Continuous	64.1 Years STANDARD_DEVIATION 8.6	64.3 Years STANDARD_DEVIATION 8.7	64.2 Years STANDARD_DEVIATION 8.6
Sex: Female, Male Female	538 Participants	512 Participants	1050 Participants
Sex: Female, Male Male	851 Participants	872 Participants	1723 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	620 / 1,389	635 / 1,378
serious Total, serious adverse events	1,140 / —	1,159 / —