Comparison · NCT02052310-deaths
Roxadustat vs Epoetin Alfa: deaths from any cause
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: deaths from any cause. Trial comparisons, record NCT02052310-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02052310-deaths
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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 | 0.123 | 0.0972 | 0.154 | wilson | |
| Risk in group 2 | 0.104 | 0.0809 | 0.134 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0182 | -0.0207 | 0.057 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.835 | 1.65 | log | |
| Odds ratio, group 1 over group 2 | 1.2 | 0.816 | 1.76 | log | |
| Number needed to harm, for one more death from any cause on Roxadustat than on Epoetin Alfa | 55.1 | 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 a tiered, weight-based dosing scheme (low weight \[≤70 kg\] and high weight \[\>70 to 160 kg\] participants received 70 and 100 mg roxadustat, respectively). Dose adjustment to achieve correction and subsequent maintenance of target Hb values (10-12 g/dL) was based upon regular monitoring of Hb. The maximum roxadustat dose was 3.0 mg/kg per dose or 400 mg per administration (whichever was lower). The maximum treatment duration was 227.9 weeks. | 64 | 522 | EG000 |
| Group 2 | Epoetin Alfa | Participants on HD received epoetin alfa, administered IV TIW, with starting doses and dose adjustment rules as per USPI or SmPC. Participants on home HD or PD received epoetin alfa, administered SC as per the country-specific product label (USPI or SmPC) or local SOC. The maximum treatment duration was 226.9 weeks. | 54 | 517 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
Baseline (Day 1, Week 0) up to 28 days after the last dose of study drug (maximum treatment duration was 227.9 weeks for roxadustat and 226.9 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 227.9 weeks for roxadustat and 226.9 weeks for epoetin alfa).
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
- NCT number
- NCT02052310
- Phases
- PHASE3
- Conditions
- Anemia in Incident Dialysis Patients
- Interventions
- Roxadustat, Epoetin Alfa
- Lead sponsor
- Kyntra Bio
- Results first posted
- 2021-10-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02052310?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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