Trial · NCT03799627
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) | Baseline; Week 10 to Week 12 | Randomized Population: All randomized participants. Analysis of this population was based on the randomized treatment. | grams per deciliter (g/dL) | MEAN |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Week 24 | Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Up to Week 24 | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Up to Week 24 | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified as Hb Outliers | Weeks 13 - 20 | Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. Only participants with available data were included in the analysis. The rows presenting data for HB \> 12.0 g/dL, HB \> 13.0 g/dL and HB \> 14.0 g/dL are mutually exclusive. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hb Values Within the Target Range at the PEP | Week 10 to Week 12 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 | Week 10 to Week 12; Week 18 to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study). | g/dL | MEAN |
| SECONDARY | Mean Change in Hb Between Baseline and the SEP | Baseline; Week 18 to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | g/dL | MEAN |
| SECONDARY | Number of Participants With Hb Values Within the Target Range at the SEP | Week 18 to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing | Week 18 to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP | Week 10 to Week 12 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP | Week 18 to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation | Up to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue | Up to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Requiring Red Blood Cell (RBC) Transfusion | Up to Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group | Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose) | Pharmacokinetic (PK) Population: all randomized participants who received study drug and had enough drug concentrations to estimate AUC and Cmax. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with concentrations below the limit of quantitation (BLQ) for all the time points were excluded from the analysis. | Milliunits per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Mean Change From Baseline in Reticulocyte Count | Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | 10^3 cells/microliter (µL) | MEAN |
| SECONDARY | Mean Change From Baseline in Iron Concentration | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | micrograms per deciliter (µg/dL) | MEAN |
| SECONDARY | Mean Change From Baseline in Ferritin Concentration | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | micrograms per liter (µg/L) | MEAN |
| SECONDARY | Mean Change From Baseline in Total Iron Binding Capacity | Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20 | Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis. | µg/dL | 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.
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