Trial · NCT01235936
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 | Baseline; Day 29 | Full Analysis Set: All participants who received at least 1 dose of study medication. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Grams per decilitre (g/dL) | MEAN |
| SECONDARY | Mean Change From Baseline in Hematocrit on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Percentage of red blood cells in blood | MEAN |
| SECONDARY | Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Million cells per cubic millimeter | MEAN |
| SECONDARY | Mean Change From Baseline in Absolute Reticulocyte Count on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Cells per Microlitre | MEAN |
| SECONDARY | Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Picograms | MEAN |
| SECONDARY | Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29 | Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29 | Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29 | Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29 | Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29 | Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Ferritin on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Nanograms per millilitre | MEAN |
| SECONDARY | Change From Baseline in Iron on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Micrograms per decilitre | MEAN |
| SECONDARY | Change From Baseline in Total Iron Binding Capacity on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Micrograms per decilitre | MEAN |
| SECONDARY | Change From Baseline in Transferrin Saturation on Day 29 | Baseline; Day 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Percentage | MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 2 weeks post 28 days of treatment | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Up to 2 weeks post 28 days of treatment | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Up to 2 weeks post 28 days of treatment | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings | Up to 2 weeks post 28 days of treatment | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval | Up to 2 weeks post 28 days of treatment | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | Milliseconds | MEAN |
| SECONDARY | Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29 | Pre-dose at Day 8, 15, 22 and 29 | Full analysis set population. Per the protocol, all results data are summarized as a single treatment arm (i.e., all participants receiving Vadadustat); no separate analysis was performed to report results by disease state. | nanograms per millilitre | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01235936/outcomes