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

Primary Purpose

Renal Failure

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

10mg Rosuvastatin

Placebo

About this trial

This is an interventional prevention trial for Renal Failure focused on measuring End Stage Renal Failure

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rosuvastatin 10mg

Placebo

Arm Description

matching Placebo

Outcomes

Primary Outcome Measures

Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)

Secondary Outcome Measures

Number of Randomised Participants That Died From Any Cause.

Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause

Number of Randomised Participants That Died From Cardiovascular Cause

Number of Randomised Participants That Died From Non Cardiovascular Cause

Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)

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.

Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).

Full Information

NCT ID

NCT00240331

First Posted

October 16, 2005

Last Updated

May 17, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00240331

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Failure

Keywords

End Stage Renal Failure

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

2776 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rosuvastatin 10mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

matching Placebo

Intervention Type

Drug

Intervention Name(s)

10mg Rosuvastatin

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)

Time Frame