Comparison · NCT01906489-b9040f9e
Vadadustat vs Placebo: Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Vadadustat vs Placebo: Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings. Trial comparisons, record NCT01906489-b9040f9e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01906489-b9040f9e
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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 | 0.00000000000000000173 | 0.0271 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0507 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0507 | 0.0271 | 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 | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Vadadustat | Participants received Vadadustat 450 milligrams (mg), as 3 tablets once daily (QD) for 20 consecutive weeks. The dose of study medication was increased to a maximum of 600 mg/day or decreased to 150 mg/day based on Hgb response. Participants received an iron supplement to maintain ferritin levels. | 0 | 138 | OG000 |
| Group 2 | Placebo | Participants were randomized to receive matching Placebo administered as 3 tablets once daily (QD) for 20 consecutive weeks. Placebo was provided as white to off-white, oval film-coated tablets for oral administration. Participants received an iron supplement to maintain ferritin levels. | 0 | 72 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
- Description
A Baseline physical examination was performed at screening. Otherwise, abbreviated physical examinations were conducted and were to include heart, lung, and abdomen. The investigator was responsible for reviewing laboratory results for clinically significant changes.
- Time frame
- Up to 20 Weeks
- Population
- ITT Population
Source ClinicalTrials.gov
Trial
- Title
- 20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
- NCT number
- NCT01906489
- Phases
- PHASE2
- Conditions
- Anemia, Chronic Kidney Disease
- Interventions
- AKB-6548, Placebo
- Lead sponsor
- Akebia Therapeutics
- Results first posted
- 2022-07-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01906489?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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