Comparison · NCT04707573-83a79154
Cohort 1: CKD Stage 3 Vadadustat vs Cohort 2: CKD Stage 4 Vadadustat: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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. Cohort 1: CKD Stage 3 Vadadustat vs Cohort 2: CKD Stage 4 Vadadustat: Number of Participants With Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT04707573-83a79154. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04707573-83a79154
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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 | 0.6 | 0.313 | 0.832 | wilson | |
| Risk in group 2 | 0.167 | 0.047 | 0.448 | wilson | |
| Risk difference, group 1 minus group 2 | 0.433 | 0.0312 | 0.694 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.6 | 0.922 | 14.1 | log | |
| Odds ratio, group 1 over group 2 | 7.5 | 1.04 | 54.1 | log | |
| Number needed to treat, for one more participant with the outcome on Cohort 1: CKD Stage 3 Vadadustat than on Cohort 2: CKD Stage 4 Vadadustat | 2.31 | 1.44 | 32.1 | from the risk difference interval |
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 | Cohort 1: CKD Stage 3 Vadadustat | Participants with CKD Stage 3 with Estimated Glomerular Filtration Rate (eGFR) 30 - 59 mL/minute received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition. | 6 | 10 | OG000 |
| Group 2 | Cohort 2: CKD Stage 4 Vadadustat | Participants with CKD Stage 4 with eGFR \<30 mL/minute and not yet on dialysis received a single dose of Vadadustat 500 milligrams (mg) (one 200 mg capsule and one 300 mg capsule) orally in fasted condition. | 2 | 12 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Description
An Adverse Event (AE) was defined as any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study following study medication administration, regardless of causal relationship. This also included any clinically significant worsening or re-occurrence of a pre-existing condition, or AE occurring from an overdose of a study drug whether accidental or intentional or AE occurring from abuse of study drug or that has been associated with the discontinuation of the use of study drug.
- Time frame
- Up to Day 8
- Population
- Intent-to-treat (ITT) population: all enrolled participants who received a dose of the study drug.
Source ClinicalTrials.gov
Trial
- Title
- Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4
- NCT number
- NCT04707573
- Phases
- PHASE2
- Conditions
- Chronic Kidney Disease
- Interventions
- Vadadustat
- Lead sponsor
- Akebia Therapeutics
- Results first posted
- 2022-05-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04707573?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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