Trial · NCT03054337
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period | Pre-treatment; Week 6 | Modified Intent-to-Treat Population (mITT): all randomized participants who received at least 1 dose of study medication, had a pre-treatment Hb average, and at least one post-Baseline Hb measurement. The mITT Population was based on the treatment to which participants were randomized. | grams per deciliter (g/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16 | from Baseline up to Week 16 | mITT Population. Only participants with Hb \< 10.0 g/dL at the Baseline visit were included in the analysis. | days | MEAN |
| SECONDARY | Mean Hb Levels at the End of the Primary Efficacy Period | up to Week 6 | mITT Population. Only participants with available data were analyzed. | g/dL | MEAN |
| SECONDARY | Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period | up to Week 16 | mITT Population. Only participants with available data were analyzed. | g/dL | MEAN |
| SECONDARY | Number of Participants Who Achieved the Target Hb Level of 10.0 to 12.0 g/dL at the End of the Dose Adjustment and Maintenance Period | up to Week 16 | mITT Population. Only participants with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period | Pre-treatment; Week 16 | mITT Population. Only participants with available data were analyzed. | g/dL | MEAN |
| SECONDARY | Mean Change in Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | mITT Population. Only participants with available data were analyzed. | 10^6 cells/microliter (μL) | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | mITT Population. Only participants with available data were analyzed. | 10^6 cells/μL | MEAN |
| SECONDARY | Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | mITT Population. Only participants with available data were analyzed. | percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | mITT Population. Only participants with available data were analyzed. | percentage | MEAN |
| SECONDARY | Mean Change in Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | mITT Population | micrograms per deciliter (μg/dL) | MEAN |
| SECONDARY | Mean Change in Iron and TIBC From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | mITT Population. Only participants with available data were analyzed. | μg/dL | MEAN |
| SECONDARY | Mean Change in Transferrin Saturation (TSAT) From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | mITT Population. Only participants with available data were analyzed. | percentage | MEAN |
| SECONDARY | Mean Change in TSAT From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | mITT Population. Only participants with available data were analyzed. | percentage | MEAN |
| SECONDARY | Mean Change in Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | mITT Population. Only participants with available data were analyzed. | nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Mean Change in Ferritin and Hepcidin From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | mITT Population. Only participants with available data were analyzed. | ng/mL | MEAN |
| SECONDARY | Number of Participants Who Required Rescue With Erythropoiesis-stimulating Agents (ESAs) From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | mITT Population. Only participants with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Required Rescue With ESAs From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | mITT Population. Only participants with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | mITT Population. Only participant with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | mITT Population. Only participants with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03054337/outcomes