Trial · NCT00773513
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
NCT00773513, Phase 4, Completed, Hoffmann-La Roche; results first posted 2018-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs). Trials, record NCT00773513. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00773513
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
- NCT number
- NCT00773513
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,825 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Chronic Renal Anemia
- Interventions
- Darbepoetin Alfa, Epoetin Alfa, Epoetin Beta, methoxy polyethylene glycol-epoetin beta
- First posted
- 2008-10-16
- Last updated
- 2019-08-20
- Results first posted
- 2018-08-15
- Limitations and caveats
- The study was designed and powered to formally test only the primary composite outcome measure only.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First | Baseline up to approximately 8.5 years | |
| Secondary | Time to All-Cause Mortality | Baseline up to approximately 8.5 years | |
| Secondary | Time to Non-Fatal and Fatal Myocardial Infarction | Baseline up to approximately 8.5 years | |
| Secondary | Time to Non-Fatal and Fatal Stroke | Baseline up to approximately 8.5 years | |
| Secondary | Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First) | Baseline up to approximately 8.5 years | |
| Secondary | Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA) | Baseline up to approximately 8.5 years | |
| Secondary | Percentage of Participants With Gastrointestinal Bleeding | Baseline up to approximately 8.5 years | |
| Secondary | Percentage of Participants With Thromboembolic Events | Baseline up to approximately 8.5 years |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First | Baseline up to approximately 8.5 years | The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event. | years | MEDIAN |
| SECONDARY | Time to All-Cause Mortality | Baseline up to approximately 8.5 years | The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event. | years | MEDIAN |
| SECONDARY | Time to Non-Fatal and Fatal Myocardial Infarction | Baseline up to approximately 8.5 years | The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event. | years | MEDIAN |
| SECONDARY | Time to Non-Fatal and Fatal Stroke | Baseline up to approximately 8.5 years | The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event. | years | MEDIAN |
| SECONDARY | Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First) | Baseline up to approximately 8.5 years | The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event. | years | MEDIAN |
| SECONDARY | Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA) | Baseline up to approximately 8.5 years | The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Gastrointestinal Bleeding | Baseline up to approximately 8.5 years | The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Thromboembolic Events | Baseline up to approximately 8.5 years | The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First | Erythropoiesis Stimulating Agents | 5.1 | 95% Confidence Interval 4.8 to 5.6 | years | |
Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First | Methoxy Polyethylene Glycol-Epoetin Beta | 5.1 | 95% Confidence Interval 4.7 to 5.4 | years | |
| Time to All-Cause Mortality | Erythropoiesis Stimulating Agents | 6.1 | 95% Confidence Interval 5.6 to 6.5 | years | |
| Time to All-Cause Mortality | Methoxy Polyethylene Glycol-Epoetin Beta | 5.9 | 95% Confidence Interval 5.5 to 6.5 | years | |
| Time to Non-Fatal and Fatal Myocardial Infarction | Erythropoiesis Stimulating Agents | NA | 95% Confidence Interval NA to NA | years | |
| Time to Non-Fatal and Fatal Myocardial Infarction | Methoxy Polyethylene Glycol-Epoetin Beta | NA | 95% Confidence Interval NA to NA | years | |
| Time to Non-Fatal and Fatal Stroke | Erythropoiesis Stimulating Agents | NA | 95% Confidence Interval NA to NA | years | |
| Time to Non-Fatal and Fatal Stroke | Methoxy Polyethylene Glycol-Epoetin Beta | NA | 95% Confidence Interval NA to NA | years | |
| Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First) | Erythropoiesis Stimulating Agents | NA | 95% Confidence Interval NA to NA | years | |
| Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First) | Methoxy Polyethylene Glycol-Epoetin Beta | NA | 95% Confidence Interval NA to NA | years |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Erythropoiesis Stimulating Agents (ESA) | 1,413 | |
| Overall Study | STARTED | Methoxy Polyethylene Glycol-Epoetin Beta | 1,412 | |
| Overall Study | Received Study Treatment | Erythropoiesis Stimulating Agents (ESA) | 1,409 | |
| Overall Study | Received Study Treatment | Methoxy Polyethylene Glycol-Epoetin Beta | 1,409 | |
| Overall Study | COMPLETED | Erythropoiesis Stimulating Agents (ESA) | 312 | |
| Overall Study | COMPLETED | Methoxy Polyethylene Glycol-Epoetin Beta | 303 | |
| Overall Study | NOT COMPLETED | Erythropoiesis Stimulating Agents (ESA) | 1,101 | |
| Overall Study | NOT COMPLETED | Methoxy Polyethylene Glycol-Epoetin Beta | 1,109 |
Source ClinicalTrials.gov
Adverse events2,626
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 | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Erythropoiesis Stimulating Agents | 171 | 1,409 | |
| other | Nasopharyngitis | Infections and infestations | Methoxy Polyethylene Glycol-Epoetin Beta | 187 | 1,409 | |
| other | Bronchitis | Infections and infestations | Erythropoiesis Stimulating Agents | 195 | 1,409 | |
| other | Bronchitis | Infections and infestations | Methoxy Polyethylene Glycol-Epoetin Beta | 188 | 1,409 | |
| other | Urinary tract infection | Infections and infestations | Erythropoiesis Stimulating Agents | 193 | 1,409 | |
| other | Urinary tract infection | Infections and infestations | Methoxy Polyethylene Glycol-Epoetin Beta | 200 | 1,409 | |
| other | Upper respiratory tract infection | Infections and infestations | Erythropoiesis Stimulating Agents | 153 | 1,409 | |
| other | Upper respiratory tract infection | Infections and infestations | Methoxy Polyethylene Glycol-Epoetin Beta | 132 | 1,409 | |
| other | Gastroenteritis | Infections and infestations | Erythropoiesis Stimulating Agents | 93 | 1,409 | |
| other | Gastroenteritis | Infections and infestations | Methoxy Polyethylene Glycol-Epoetin Beta | 101 | 1,409 |
1 to 10 of 2,626Source ClinicalTrials.gov
See all 2,626 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erythropoiesis Stimulating Agents | 557 | 1,409 |
| Total, all-cause mortality | Methoxy Polyethylene Glycol-Epoetin Beta | 558 | 1,409 |
| Total, other adverse events | Erythropoiesis Stimulating Agents | 1,171 | 1,409 |
| Total, other adverse events | Methoxy Polyethylene Glycol-Epoetin Beta | 1,177 | 1,409 |
| Total, serious adverse events | Erythropoiesis Stimulating Agents | 1,123 | 1,409 |
| Total, serious adverse events | Methoxy Polyethylene Glycol-Epoetin Beta | 1,097 | 1,409 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Erythropoiesis Stimulating Agents vs Methoxy Polyethylene Glycol-Epoetin Beta: deaths from any cause | Trial comparisons |
| Erythropoiesis Stimulating Agents vs Methoxy Polyethylene Glycol-Epoetin Beta: serious adverse events | 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.
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/NCT00773513
GET https://conductscience.org/api/trials/v1/NCT00773513/events?page=2