Trial · NCT02689206
Outcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hgb Levels at Day 29 | Baseline and Day 29 | ITT Population | g/dL | MEAN |
| SECONDARY | Maximum Observed Change From Baseline in Plasma Erythropoietin (EPO) | Baseline and up to Day 29 | ITT Population | International unit per liter (IU/L) | MEAN |
| SECONDARY | Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF) | Baseline and up to Day 29 | ITT Population | Nanograms per liter (ng/L) | GEOMETRIC_MEAN |
| SECONDARY | Percent Change From Baseline in Hepcidin at Day 29 | Baseline and Day 29 | ITT Population | Micrograms per liter (µg/L) | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Hematocrit Levels | Baseline and Day 29 | ITT Population | Proportion of red blood cells in blood | MEAN |
| SECONDARY | Change From Baseline in Red Blood Cell (RBC) Count | Baseline and Day 29 | ITT Population | 10^12 cells/L | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Count | Baseline and Day 29 | ITT Population | Percentage of reticulocyte | MEAN |
| SECONDARY | Change From Baseline in Reticulocyte Hemoglobin (CHr) | Baseline and Day 29 | ITT Population | Picograms (pg) | MEAN |
| SECONDARY | Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) and AUC From Time Zero to Infinity (AUC[0-inf]) of Dapro | Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29 | PK Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses. | hour into nanograms/milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Concentration of Dapro in Plasma (Cmax) | Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29 | PK Population | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Cmax (Tmax) and Apparent Terminal Half-life (t1/2) of Dapro | Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29 | PK Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses. | Hour | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants Who Discontinued Study Treatment | Up to Day 43 | Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses. | Participants | NUMBER |
| SECONDARY | Number of Participants With AEs and Serious Adverse Events (SAEs) | Up to Day 43 | Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses. | Participants | NUMBER |
| SECONDARY | Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points | Up to Day 43 | Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Albumin and Protein Levels in Blood at Indicated Tme Points | Up to Day 43 | Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses. | grams per liter (g/L) | MEAN |
| SECONDARY | Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points | Up to Day 43 | Safety Population One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses. | IU/L | MEAN |
| SECONDARY | Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points | Up to Day 43 | Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses. | Micromoles per liter (µmol/L) | MEAN |
| SECONDARY | Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels | Baseline and up to Day 43 | Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses. | Mmol/L | MEAN |
| SECONDARY | Change From Baseline in Albumin and Protein Levels | Baseline and up to Day 43 | Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses. | g/L | MEAN |
| SECONDARY | Change From Baseline in ALT, AST, Alk. Phosph. Levels | Baseline and up to Day 43 | Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses. | IU/L | 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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