Trial · NCT02969655
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | Intent to treat (ITT) Population comprised of all randomized participants who had a Baseline and at least one post Baseline schedule Hgb assessment. | Grams per deciliter (g/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | Modified Intent to treat (mITT) comprised of all ITT participants who had at least one Hgb measurement during the evaluation period. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hgb (Hgb Increase Rate) at Week 4 | Baseline and Week 4 | ITT Population | g/dL | MEAN |
| SECONDARY | Percentage of Participants by Hgb Change From Baseline Category at Week 4 | Week 4 | ITT Population. Data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency. | Percentage of participants | NUMBER |
| SECONDARY | Distribution of Daprodustat Dose Level by Visit | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44, and 48) | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). | milligrams per day (mg/day) | MEDIAN |
| SECONDARY | Distribution of Darbepoetin Alfa Dose Level by Visit | Day 1, Weeks 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48, and 50 | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). | micrograms per week (ug/week) | MEDIAN |
| SECONDARY | Duration of Treatment Interruption Due to Hgb >13 g/dL | Up to Week 52 | ITT Population. Only those participants with data available at the time of assessment were used for analysis. Summary data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency. Median along with inter quartile range (25th and 75th percentile) have been presented. | Days | MEDIAN |
| SECONDARY | Number of Dose Adjustments for Daprodustat | Up to Week 52 | ITT Population. Summary data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency. | Dose adjustments | MEDIAN |
| SECONDARY | Hgb Values at Each Assessment Visit | Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). | g/dL | MEAN |
| SECONDARY | Change From Baseline in Hgb Values at Each Assessment Visit | Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). | g/dL | MEAN |
| SECONDARY | Percentage of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) at Each Assessment Visit | Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Time in Hgb Target Range (10.0 to 12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | ITT Population. Only those participants with data available at the indicated time point were analyzed. | Percentage of time | MEAN |
| SECONDARY | Number of Participants Who Had an Hgb Level of Less Than 7.5 g/dL | Up to Week 52 | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | Up to Week 52 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Had an Hgb Level of More Than 13.0 g/dL | Up to Week 52 | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Number of Episodes With Hgb Level of More Than 13.0 g/dL | Up to Week 52 | ITT Population | Episodes | NUMBER |
| SECONDARY | Area Under Plasma Concentration Curve From Time Zero to 4 Hours (AUC [0 - 4]) of Plasma Daprodustat | 0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24 | PK Population | Hours*nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Maximum Concentration (Cmax) of Plasma Daprodustat | 0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24 | PK Population | Nanograms per milliliter | GEOMETRIC_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.
For software
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GET https://conductscience.org/api/trials/v1/NCT02969655/outcomes