Comparison · NCT02648347-sae
Vadadustat vs Darbepoetin 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. Vadadustat vs Darbepoetin Alfa: serious adverse events. Trial comparisons, record NCT02648347-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02648347-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 | 0.653 | 0.621 | 0.683 | wilson | |
| Risk in group 2 | 0.645 | 0.612 | 0.676 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00779 | -0.0369 | 0.0525 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.945 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.85 | 1.26 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Vadadustat than on Darbepoetin Alfa | 128 | 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 | Vadadustat | Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels. | 573 | 878 | EG000 |
| Group 2 | Darbepoetin Alfa | Participants were randomized to Darbepoetin alfa at an initial dose that was based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics (SmPC) for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. | 561 | 870 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 208 weeks
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease
- NCT number
- NCT02648347
- Phases
- PHASE3
- Conditions
- Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
- Interventions
- Vadadustat, Darbepoetin alfa
- Lead sponsor
- Akebia Therapeutics
- Results first posted
- 2022-06-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02648347?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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