| Outcome Measures: |
Primary: Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO, Blood samples were collected at indicated time points for analysis of fractional oral iron absorption following treatment with Daprodustat and rhEPO. Adjusted mean and 95 percent (%) confidence interval (CI) has been presented., Up to Day 57 | Secondary: Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO, Blood samples were collected for measurement of serum iron at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO, Blood samples were collected from participants for measurement of transferrin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO, Blood samples were collected from participants for measurement of transferrin saturation at indicated time points. Transferrin saturation was measured as a percentage and is the ratio of serum iron and total iron-binding capacity multiplied by 100. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO, Blood samples were collected from participants for measurement of soluble transferrin receptor at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO, Blood samples were collected from participants for measurement of ferritin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The summary of log transformed ration to baseline on markers of iron status for Ferritin is presented here., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO, Blood samples were collected from participants for measurement of hepcidin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The summary of log transformed ration to baseline on markers of iron status for Hepcidin is presented here., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO, Blood samples were collected from participants for measurement of erythroferrone at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO, Blood samples were collected from participants for measurement of hemoglobin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO, Blood samples were collected from participants for measurement of hematocrit at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Periods 1 and 2: Change From Baseline in Erythrocytes Following Treatment With Daprodustat and rhEPO, Blood samples were collected from participants for measurement of erythrocytes (red blood cells number) at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Periods 1 and 2: Change From Baseline in Erythrocyte Mean Corpuscular Volume Following Treatment With Daprodustat and rhEPO, Blood samples were collected from participants for measurement of erythrocyte mean corpuscular volume at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Periods 1 and 2: Change From Baseline in Reticulocyte Hemoglobin Following Treatment of Daprodustat and rhEPO, Blood samples were collected from participants for measurement of reticulocyte hemoglobin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)|Periods 1 and 2: Change From Baseline in Reticulocytes Following Treatment With Daprodustat and rhEPO, Blood samples were collected from participants for measurement of reticulocytes number at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
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| Locations: |
GSK Investigational Site, Fort Worth, Texas, 76104, United States|GSK Investigational Site, Lufkin, Texas, 75904, United States|GSK Investigational Site, San Antonio, Texas, 78212, United States
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