Trial · NCT02260193
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average | Pre-dose (Screening, Second Screening, and Baseline), Week 7, and Week 8 | Modified Intent-to-treat (MITT) Population: All participants who were assigned to study medication, received at least 1 dose of study medication, and had a pre-dose average and at least one post-baseline Hgb measurement. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data. | Grams per deciliter (g/dL) | MEAN |
| PRIMARY | Change From Pre-dose Average in Hgb Level to The End-of-study Average | Pre-dose, Week 15, and Week 16 | MITT Population. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data. | g/dL | MEAN |
| PRIMARY | Change From Mid-study Average in Hgb Level to The End-of-study Average | Week 7, Week 8, Week 15, and Week 16 | MITT Population. The primary analysis was performed in the MITT population using observed Hgb data without imputation for missing data. | g/dL | MEAN |
| SECONDARY | Change From Baseline in Hgb | Baseline, Week 4, Week 8, Week 12, and Week 16 | MITT Population | g/dL | MEAN |
| SECONDARY | Change From Baseline in Hematocrit | Baseline, Week 4, Week 8, Week 12, and Week 16 | MITT Population | Percentage of red blood cells in blood | MEAN |
| SECONDARY | Change From Baseline in Red Blood Cell (RBC) Count | Baseline, Week 4, Week 8, Week 12, and Week 16 | MITT Population | 10^6 cells per microliter | MEAN |
| SECONDARY | Change From Baseline in Absolute Reticulocyte Count | Baseline, Week 4, Week 8, Week 12, and Week 16 | MITT Population | 10^6 cells per microliter | MEAN |
| SECONDARY | Change From Baseline in Percent Reticulocyte Count | Baseline, Week 4, Week 8, Week 12, and Week 16 | MITT Population | Percent change | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Hgb Content | Baseline, Week 2, Week 4, Week 8, and Week 16 | MITT Population | μg/dL | MEAN |
| SECONDARY | Change From Baseline in Ferritin | Baseline, Week 4, Week 8, Week 12, and Week 16 | MITT Population | Nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Change From Baseline in Hepcidin | Baseline, Week 8, and Week 16 | MITT Population | Nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Change From Baseline in Total Iron-Binding Capacity (TIBC) | Baseline, Week 4, Week 8, Week 12, and Week 16 | MITT Population | Micrograms per deciliter (μg/mL) | MEAN |
| SECONDARY | Change From Baseline in Transferrin Saturation (TSAT) | Baseline, Week 4, Week 8, Week 12, and Week 16 | MITT Population | Percent change | MEAN |
| SECONDARY | Change From Baseline in Iron | Baseline, Week 4, Week 8, Week 12, and Week 16 | MITT Population | μg/dL | MEAN |
| SECONDARY | Number of Participants Who Received Erythropoiesis-stimulating Agent (ESA) Rescue Therapy | Up to Week 16 | Intent-to-treat (ITT) Population: All participants who were assigned to study medication and received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Received Blood Transfusion Rescue Therapy | Up to Week 16 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Plasma Concentrations of Vadadustat | Pre-dialysis and post-dialysis on Week 2 and Week 16 | ITT Population. Participants with available data were included in the analysis. | μg/mL | MEAN |
| SECONDARY | Mean Plasma Concentrations of Vadadustat-O-Glucuronide Metabolite | Pre-dialysis and post-dialysis on Week 2 and Week 16 | ITT Population. Participants with available data were included in the analysis. | μg/mL | MEAN |
| SECONDARY | Mean Plasma Concentrations of Vadadustat-Acyl-Glucuronide Metabolite | Pre-dialysis and post-dialysis on Week 2 and Week 16 | ITT Population. Participants with available data were included in the analysis. | μg/mL | MEAN |
| SECONDARY | Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to Week 20 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02260193/outcomes