Comparison · NCT04707573-85a4ddc6
Cohort 1: CKD Stage 3 Vadadustat vs Cohort 2: CKD Stage 4 Vadadustat: Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
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 Clinically Significant Changes From Baseline in Vital Sign Values. Trial comparisons, record NCT04707573-85a4ddc6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04707573-85a4ddc6
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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 | 0.2 | 0.0567 | 0.51 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.242 | wilson | |
| Risk difference, group 1 minus group 2 | 0.2 | -0.0817 | 0.51 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| 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 | 5 | 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 | 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. | 2 | 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. | 0 | 12 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
- Description
Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing laboratory results for clinically significant changes. Number of participants with a clinically significant change from baseline in at least one of the assessed vital signs parameters is reported.
- Time frame
- Up to Day 8
- Population
- ITT Population
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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