Trial · NCT02075463
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Demonstrating an Increase in Hgb of >=1 g/dL (if Baseline Hgb is <9.5 g/dL), or >=0.5 g/dL (if Baseline Hgb is 9.5-<10 g/dL), or Stay Within Target Range and do Not Drop by >0.5 g/dL (if Baseline Hgb is >= 10 g/dL) at Week 16 | Week 16 | Percentage of participants with increased Hgb \>=1 g/dL (if baseline Hgb is \<9.5 g/dL), or \>=0.5 g/dL (if baseline Hgb is 9.5-\<10 g/dL), or within the target range and not dropped by \>0.5 g/dL (if baseline Hgb is \>= 10 g/dL) at Week 16 are presented. Participants who were available at the indicated time point were analyzed |
| Secondary | Change From Baseline in Hgb Levels at Week 16 | Week 16 | Hgb values measured at Week 16 are presented. Change from baseline was calculated as Week 16 minus baseline value . Participants who were available at the indicated time point were analyzed. |
| Secondary | Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point | Week 12 to Week 16 | The percentage of time in Hgb levels were in target range (10.0 to 11.5 g/dL) between Weeks 12 and 16 for a participant was calculated by adding the total number of days that Hgb is within target range while on treatment during Weeks 12 to 16 and dividing by the total number of days the participant remained on treatment during Weeks 12 to 16 (using Rosendaal linear interpolation method). Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated. Participants who were available at the indicated time point were analyzed. |
| Secondary | Number of Participants Achieving at Least 1 g/dL Increase in Hgb From Baseline at Week 16 | Baseline and Week 16 | Number of participants achieving at least 1 g/dL increase in Hgb from baseline at Week 16 were presented. Participants who were available at the indicated time point were analyzed. |
| Secondary | Number of Participants With Hgb in the Target Range at Week 16 | Week 16 | The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 16 were analyzed. Participants who were available at the indicated time point were analyzed. |
| Secondary | Number of Participants Reaching Pre-defined Hgb Stopping Criteria | Up to Week 16 | The number of participants who reached the Hgb stopping criteria of Hgb concentration \<7.5 g/dL from baseline to Week 16 were presented. Participants who were available at the indicated time point were analyzed. |
| Secondary | Percent Change From Baseline in Hepcidin at Week 16 | Baseline (Day 1) and Week 16 | Hepcidin is a regulator of iron metabolism. Baseline value for hepcidin is the pre-dose value on Day 1. Percent change was calculated as 100 multiplied by \[exponential (log Week 16 value - log Baseline value) minus 1\]. Participants who were available at the indicated time point were analyzed. |
| Secondary | Change From Baseline in Ferritin at Week 16 | Baseline (Day 1) and Week 16 | Baseline value for ferritin is the last pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed. |
| Secondary | Change From Baseline in Transferrin at Week 16 | Baseline (Day 1) and Week 16 | Baseline value for transferrin is the last pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed. |
| Secondary | Percent Change From Baseline in Transferrin Saturation at Week 16 | Baseline (Day 1) and Week 16 | Transferrin saturation is measured in percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change is 100 times \[exponential (log Week 16 value minus log Baseline value) -1\]. Participants who were available at the indicated time point were analyzed. |
| Secondary | Change From Baseline in Total Iron at Week 16 | Baseline (Day 1) and Week 16 | Baseline value for total iron is the last pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points. |
| Secondary | Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16 | Baseline (Day 1) and Week 16 | Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the last pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points. |
| Secondary | Reticulocyte Hgb Content (CHr) at Week 16 | Week 16 | Data has been presented for only those participants who were available at indicated timepoints |
| Secondary | Mean Corpuscular Volume (MCV) at Week 16 | Week 16 | Data has been presented for only those participants who were available at indicated time points. |
| Secondary | Mean Corpuscular Hemoglobin (MCH) at Week 16 | Week 16 | Data has been presented for only those participants who were available at indicated time points. |
| Secondary | Change From Baseline in Hematocrit at Week 16 | Baseline (Day 1) and Week 16 | Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points. |
| Secondary | Change From Baseline in Red Blood Cell (RBC) at Week 16 | Baseline (Day 1) and Week 16 | Baseline value for RBC (or erythrocytes) is the last pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points |
| Secondary | Change From Baseline in Reticulocyte Number at Week 16 | Baseline (Day 1) and Week 16 | Baseline value for reticulocyte number is the pre-dose value on Day 1. Change from Baseline in reticulocyte number was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points. |
| Secondary | Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF) | Baseline (Day 1) to Week 16 | Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF in the subjects was reported. Baseline value for VEGF is the last pre-dose value on Day 1. Percent change was calculated as 100 multiplied by exponential (log observed maximum value minus log Baseline value) minus 1. Participants who were available at the indicated time point were analyzed. |
| Secondary | Maximum Observed Change From Baseline in Erythropoietin (EPO) | Baseline (Day 1) to Week 16 | Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was reported. Baseline value for EPO is the last pre-dose value on Day 1. Change from baseline is calculated as the maximum observed value minus the baseline value. Participants who were available at the indicated time point were analyzed. |
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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