Trial · NCT03054350
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 | Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period | Pre-treatment; Week 6 | The pre-treatment average value for Hb was defined as the average of 3 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 6 value minus the Pre-treatment value. |
| 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 | Time for this analysis was measured from Day 1 (Baseline) through the point in time during either the Primary Efficacy Period or the Dose Adjustment and Maintenance Period when a participant's Hb level achieved the target range of 10.0 to 12.0 g/dL. |
| Secondary | Mean Hb Levels at the End of the Primary Efficacy Period | up to Week 6 | Data are reported as mean of the actual Week 6 values. |
| Secondary | Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period | up to Week 16 | Data are reported as mean of the actual Week 16 values. |
| 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 | |
| Secondary | Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period | Pre-treatment; Week 16 | A pre-treatment average value for Hb was defined as the average of 3 values obtained prior to dosing, i.e., the 2 qualifying screening values and the Baseline value. Change from Pre-treatment was calculated as the Week 16 value minus the Pre-treatment value. |
| 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 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| 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 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change in Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change in Iron and TIBC From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change in Transferrin Saturation (TSAT) From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change in TSAT From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change in Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change in Ferritin and Hepcidin From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Primary Efficacy Period | Baseline; Week 6 | Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study. |
| Secondary | Number of Participants Who Required Rescue With RBC Transfusion From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study. |
| 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 | ESA rescue is defined as participants with ESA administration and 1) the participant experienced a clinically significant worsening of their anemia or symptoms of anemia, 2) the participant's Hb level is \<9.0 g/dL, and 3) reason for early study withdrawal of worsening of anemia requiring ESA rescue or blood transfusion. Participants who initiated rescue therapy (including ESAs) were required to stop study drug treatment and were discontinued from the study. |
| Secondary | Number of Participants Who Required Rescue With ESAs From Baseline to the End of the Dose Adjustment and Maintenance Period | Baseline; Week 16 | ESA rescue is defined as participants with ESA administration and 1) the participant experienced a clinically significant worsening of their anemia or symptoms of anemia, 2) the participant's Hb level is \<9.0 g/dL, and 3) reason for early study withdrawal of worsening of anemia requiring ESA rescue or blood transfusion. Participants who initiated rescue therapy (including ESAs) were required to stop study drug treatment and were discontinued from the study. |
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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GET https://conductscience.org/api/trials/v1/NCT03054350/registered