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

Phase 3

Completed

• Conditions: Renal Failure
• Interventions: Drug: 10mg Rosuvastatin; Drug: Placebo

• Registration Number: NCT00240331
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-10-16
• Study First Submitted QC: 2005-10-16
• Study First Posted: 2005-10-18
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-09-29
• Results First Submitted QC: 2009-09-29
• Results First Posted: 2009-11-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-17
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2776

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin 10mg	10mg Rosuvastatin	-
Placebo	Placebo	matching Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Surrey, United Kingdom