Comparison · NCT02273726-sae
Roxadustat vs Epoetin Alfa: serious adverse events
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. Roxadustat vs Epoetin Alfa: serious adverse events. Trial comparisons, record NCT02273726-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02273726-sae
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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 | 0.654 | 0.604 | 0.701 | wilson | |
| Risk in group 2 | 0.67 | 0.621 | 0.716 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0162 | -0.084 | 0.0518 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.976 | 0.88 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.93 | 0.686 | 1.26 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Roxadustat than on Epoetin Alfa | 61.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Roxadustat | Participants received roxadustat tablets, administered orally TIW. Initial roxadustat dose was based on the participant's average prescribed ESA dose in the 4 weeks (if on epoetin or darbepoetin or 8 weeks (if on Mircera®) prior to randomization. Dose adjustments were permitted to maintain a Hb level of approximately 11 g/dL. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 183.7 weeks. | 242 | 370 | EG000 |
| Group 2 | Epoetin Alfa | Participants on HD received epoetin alfa, administered IV TIW and participants on home HD or PD received epoetin alfa, administered SC. Initial epoetin alfa dose was based on the participant's average weekly prescribed ESA dose in 4 weeks prior to randomization if on epoetin or darbepoetin, and average monthly (4-week) prescribed ESA dose in 8 weeks prior to randomization if on Mircera®. In case of a change in route of administration from SC to IV (TIW), the initial dose of IV epoetin alfa was determined by the investigator per local SOC. Dose adjustments followed the recommendations as per the approved country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 180.4 weeks. | 248 | 370 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Baseline (Day 1, Week 0) up to 28 days after the last dose of study drug (maximum treatment duration was 183.7 weeks for roxadustat and 180.4 weeks for epoetin alfa). Mortality presented is for the timeframe of Baseline (Day 1, Week 0) up to end of treatment (maximum treatment duration was 183.7 weeks for roxadustat and 180.4 weeks for epoetin alfa).
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis
- NCT number
- NCT02273726
- Phases
- PHASE3
- Conditions
- CKD Anemia in Stable Dialysis Patients
- Interventions
- Epoetin Alfa, Roxadustat
- Lead sponsor
- Kyntra Bio
- Results first posted
- 2021-10-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02273726?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT02273726-sae