Trial · NCT02260193
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Change from pre-dose average was calculated by the mid-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits. |
| Primary | Change From Pre-dose Average in Hgb Level to The End-of-study Average | Pre-dose, Week 15, and Week 16 | Change from pre-dose average was calculated by the end-of-study average minus the pre-dose average. The pre-dose average was defined as the average of the 3 Hgb values that were obtained before dosing at the first screening visit, the second screening visit, and the Baseline visit; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits. |
| Primary | Change From Mid-study Average in Hgb Level to The End-of-study Average | Week 7, Week 8, Week 15, and Week 16 | Change from mid-study average was calculated by the end-of-study average minus the mid-study average. The mid-study average was defined as the average of the 2 Hgb values that were obtained at the Week 7 and Week 8 visits; the end-of-study average was defined as the average of the 2 Hgb values that were obtained at the Week 15 and Week 16 visits. |
| Secondary | Change From Baseline in Hgb | Baseline, Week 4, Week 8, Week 12, and Week 16 | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hgb was defined as the average of the three samples obtained prior to dosing. |
| Secondary | Change From Baseline in Hematocrit | Baseline, Week 4, Week 8, Week 12, and Week 16 | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline Hematocrit was defined as the last observation before the first dose of study medication. |
| Secondary | Change From Baseline in Red Blood Cell (RBC) Count | Baseline, Week 4, Week 8, Week 12, and Week 16 | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline RBC Count was defined as the average of the three samples obtained prior to dosing. |
| Secondary | Change From Baseline in Absolute Reticulocyte Count | Baseline, Week 4, Week 8, Week 12, and Week 16 | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline absolute reticulocyte count was defined as the last observation before the first dose of study medication. |
| Secondary | Change From Baseline in Percent Reticulocyte Count | Baseline, Week 4, Week 8, Week 12, and Week 16 | Change from Baseline was calculated as (visit value minus the Baseline value)/ Baseline value x 100. Baseline percent reticulocyte count was defined as the last observation before the first dose of study medication. |
| Secondary | Change From Baseline in Reticulocyte Hgb Content | Baseline, Week 2, Week 4, Week 8, and Week 16 | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline reticulocyte Hgb content was defined as the average of the three samples obtained prior to dosing. |
| Secondary | Change From Baseline in Ferritin | Baseline, Week 4, Week 8, Week 12, and Week 16 | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline ferritin was defined as the last observation before the first dose of study medication. |
| Secondary | Change From Baseline in Hepcidin | Baseline, Week 8, and Week 16 | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline hepcidin was defined as the last observation before the first dose of study medication. |
| Secondary | Change From Baseline in Total Iron-Binding Capacity (TIBC) | Baseline, Week 4, Week 8, Week 12, and Week 16 | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline TIBC was defined as the last observation before the first dose of study medication. |
| Secondary | Change From Baseline in Transferrin Saturation (TSAT) | Baseline, Week 4, Week 8, Week 12, and Week 16 | Change from Baseline was calculated as (visit value minus the Baseline value)/ Baseline value x 100. Baseline TSAT was defined as the last observation before the first dose of study medication. |
| Secondary | Change From Baseline in Iron | Baseline, Week 4, Week 8, Week 12, and Week 16 | Change from Baseline was calculated as the visit value minus the Baseline value. Baseline iron was defined as the last observation before the first dose of study medication. |
| Secondary | Number of Participants Who Received Erythropoiesis-stimulating Agent (ESA) Rescue Therapy | Up to Week 16 | ESA rescue therapy was administered in participants with Hgb ≤12.5 g/dL, and was stopped when Hgb reached ≥13.0 g/dL. |
| Secondary | Number of Participants Who Received Blood Transfusion Rescue Therapy | Up to Week 16 | Blood transfusion rescue therapy was administered in participants with Hgb ≤12.5 g/dL, and was stopped when Hgb reached ≥13.0 g/dL. |
| Secondary | Mean Plasma Concentrations of Vadadustat | Pre-dialysis and post-dialysis on Week 2 and Week 16 | Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session. |
| Secondary | Mean Plasma Concentrations of Vadadustat-O-Glucuronide Metabolite | Pre-dialysis and post-dialysis on Week 2 and Week 16 | Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session. |
| Secondary | Mean Plasma Concentrations of Vadadustat-Acyl-Glucuronide Metabolite | Pre-dialysis and post-dialysis on Week 2 and Week 16 | Blood samples for determination of plasma levels of Vadadustat were drawn just before and 10 minutes after completion of the dialysis session. |
| Secondary | Number of Participants Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to Week 20 | An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. A TEAE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. A SAE included AEs that met one or more of the following criteria/outcomes: death, lifethreatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, and congenital anomaly/birth defect. |
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
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