Trial · NCT00240331

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

NCT00240331, Phase 3, Completed, AstraZeneca; results first posted 2009-11-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD). Trials, record NCT00240331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00240331

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)
NCT number: NCT00240331
Status: Completed
Phases: Phase 3
Enrollment: 2,776 participants, actual
Lead sponsor: AstraZeneca
Conditions: Renal Failure
Interventions: 10mg Rosuvastatin, Placebo
First posted: 2005-10-18
Last updated: 2011-05-19
Results first posted: 2009-11-04
Limitations and caveats: The endpoints were originally intended to be time to event endpoints, however we are unable to report the data as intended due to the nature of time to event endpoints. Therefore we have reported the number of participants who reached the event.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	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	Participants	NUMBER
SECONDARY	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	Participants	NUMBER
SECONDARY	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	Participants	NUMBER
SECONDARY	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	Participants	NUMBER
SECONDARY	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	Participants	NUMBER
SECONDARY	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	Participants	NUMBER
SECONDARY	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	Participants	NUMBER
SECONDARY	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	Participants	NUMBER

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)	Rosuvastatin 10mg	396	Participants
Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)	Placebo	408	Participants
Number of Randomised Participants That Died From Any Cause.	Rosuvastatin 10mg	636	Participants
Number of Randomised Participants That Died From Any Cause.	Placebo	660	Participants
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause	Rosuvastatin 10mg	614	Participants
Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause	Placebo	645	Participants
Number of Randomised Participants That Died From Cardiovascular Cause	Rosuvastatin 10mg	324	Participants
Number of Randomised Participants That Died From Cardiovascular Cause	Placebo	324	Participants
Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)	Rosuvastatin 10mg	258	Participants
Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)	Placebo	256	Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Rosuvastatin 10mg	1,389
Overall Study	STARTED	Placebo	1,384
Overall Study	COMPLETED	Rosuvastatin 10mg	1,263
Overall Study	COMPLETED	Placebo	1,250
Overall Study	NOT COMPLETED	Rosuvastatin 10mg	126
Overall Study	NOT COMPLETED	Placebo	134

Source ClinicalTrials.gov

Adverse events1,878

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Rosuvastatin 10mg	81	1,389
other	Anaemia	Blood and lymphatic system disorders	Placebo	62	1,378
other	Atrial Fibrillation	Cardiac disorders	Rosuvastatin 10mg	70	1,389
other	Atrial Fibrillation	Cardiac disorders	Placebo	59	1,378
other	Diarrhoea	Gastrointestinal disorders	Rosuvastatin 10mg	202	1,389
other	Diarrhoea	Gastrointestinal disorders	Placebo	188	1,378
other	Vomiting	Gastrointestinal disorders	Rosuvastatin 10mg	112	1,389
other	Vomiting	Gastrointestinal disorders	Placebo	127	1,378
other	Nausea	Gastrointestinal disorders	Rosuvastatin 10mg	121	1,389
other	Nausea	Gastrointestinal disorders	Placebo	97	1,378

1 to 10 of 1,878Source ClinicalTrials.gov

See all 1,878 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rosuvastatin 10mg
Total, all-cause mortality	Placebo
Total, other adverse events	Rosuvastatin 10mg	620	1,389
Total, other adverse events	Placebo	635	1,378
Total, serious adverse events	Rosuvastatin 10mg	1,140
Total, serious adverse events	Placebo	1,159

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19332456	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Rosuvastatin 10mg vs Placebo: Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).	Trial comparisons
Rosuvastatin 10mg vs Placebo: Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)	Trial comparisons
Rosuvastatin 10mg vs Placebo: 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.	Trial comparisons
Rosuvastatin 10mg vs Placebo: Number of Randomised Participants That Died From Any Cause.	Trial comparisons
Rosuvastatin 10mg vs Placebo: Number of Randomised Participants That Died From Cardiovascular Cause	Trial comparisons
Rosuvastatin 10mg vs Placebo: Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)	Trial comparisons
Rosuvastatin 10mg vs Placebo: Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00240331

GET https://conductscience.org/api/trials/v1/NCT00240331/events?page=2

API reference For AI assistants