Trial · NCT01235936
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Hemoglobin (Hgb) on Day 29 | Baseline; Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates that hemoglobin concentration increased. |
| Secondary | Mean Change From Baseline in Hematocrit on Day 29 | Baseline; Day 29 | Blood samples were collected to assess hematocrit. A positive change from baseline indicates hematocrit concentration increased. |
| Secondary | Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29 | Baseline; Day 29 | Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates RBC count increased. |
| Secondary | Mean Change From Baseline in Absolute Reticulocyte Count on Day 29 | Baseline; Day 29 | Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline). A positive change from baseline indicates absolute reticulocyte count increased. |
| Secondary | Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29 | Baseline; Day 29 | Blood samples were collected to assess reticulocyte Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates reticulocyte Hgb content increased. |
| Secondary | Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29 | Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). |
| Secondary | Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29 | Day 29 | Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). |
| Secondary | Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29 | Day 29 | Blood samples were collected to assess hematocrit. |
| Secondary | Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29 | Day 29 | Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). |
| Secondary | Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29 | Day 29 | Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline). |
| Secondary | Change From Baseline in Ferritin on Day 29 | Baseline; Day 29 | Blood samples were collected to assess ferritin. A positive change from baseline indicates ferritin content increased. |
| Secondary | Change From Baseline in Iron on Day 29 | Baseline; Day 29 | Blood samples were collected to assess iron. A positive change from baseline indicates iron content increased. |
| Secondary | Change From Baseline in Total Iron Binding Capacity on Day 29 | Baseline; Day 29 | Blood samples were collected to assess total iron binding capacity. A positive change from baseline indicates total iron binding capacity increased. |
| Secondary | Change From Baseline in Transferrin Saturation on Day 29 | Baseline; Day 29 | Blood samples were collected to assess transferrin saturation. The transferrin saturation is the ratio of the serum iron concentration and the total iron-binding capacity, expressed as a percentage. A positive change from baseline indicates transferrin saturation increased. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 2 weeks post 28 days of treatment | An Adverse Event (AE) was defined as any untoward medical occurrence, signs, symptoms, disease, or laboratory or physiological observations occurring in a participant administered with drug, regardless of a causal relationship with that treatment or usage. This also included all suspected adverse medication reactions, reactions from medication overdose, abuse, withdrawal, sensitivity, toxicity, unrelated illnesses, including worsening a pre-existing condition, injury, or accidents. Serious Adverse Events (SAEs) was defined as any life-threatening condition; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or death. |
| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Up to 2 weeks post 28 days of treatment | Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes. |
| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Up to 2 weeks post 28 days of treatment | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing laboratory results for clinically significant changes. |
| Secondary | Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings | Up to 2 weeks post 28 days of treatment | A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance. |
| 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 | A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected). |
| Secondary | Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29 | Pre-dose at Day 8, 15, 22 and 29 | Serum samples were collected from the participants at the defined time points. Trough concentration was defined as the concentration of drug in the blood immediately before the next dose is administered. Trough concentration was calculated using the validated liquid chromatography-mass spectrometry (LC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) method |
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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