Comparison · NCT00093015-5414d41a
Darbepoetin Alfa vs Placebo: Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Darbepoetin Alfa vs Placebo: Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA). Trial comparisons, record NCT00093015-5414d41a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00093015-5414d41a
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.314 | 0.294 | 0.335 | wilson | |
| Risk in group 2 | 0.297 | 0.278 | 0.317 | wilson | |
| Risk difference, group 1 minus group 2 | 0.017 | -0.0114 | 0.0454 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.963 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.948 | 1.24 | log | |
| Number needed to treat, for one more participant with the outcome on Darbepoetin Alfa than on Placebo | 58.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Darbepoetin Alfa | Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed. | 632 | 2,012 | OG001 |
| Group 2 | Placebo | Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was \<9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL. | 602 | 2,026 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)
- Description
Time from randomization to the first confirmed composite event. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.
- Time frame
- Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first
- Population
- The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.
Source ClinicalTrials.gov
Trial
- Title
- Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)
- NCT number
- NCT00093015
- Phases
- PHASE3
- Conditions
- Kidney Disease, Diabetes Mellitus, Anemia
- Interventions
- Placebo, darbepoetin alfa
- Lead sponsor
- Amgen
- Results first posted
- 2010-09-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00093015?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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