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

Study Overview
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Brief Summary
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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
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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

Conditions
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Renal Failure

Intervention / Treatment
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* Drug: 10mg Rosuvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin 10mg<br> | Drug: 10mg Rosuvastatin<br> <br> |
| Placebo Comparator: Placebo<br>matching Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End Stage Renal Failure