| Outcome Measures: |
Primary: Change From Baseline in Hgb at Week 4, Blood samples were collected from participants for measurement of Hgb values. The Baseline value was the latest pre-dose assessment. Change from Baseline at Week 4 was calculated by subtracting Baseline value from the post-dose visit value. The analysis was performed on All Treated Subjects Population which comprised of all participants who received at least one dose of GSK1278863., Baseline and Week 4|Number of Participants by Hgb Change From Baseline Category at Week 4, Blood samples were collected from participants for measurement of Hgb values. The Baseline value was the latest pre-dose assessment. Change from Baseline at Week 4 was calculated by subtracting Baseline value from the post-dose visit value. The change in Hgb at Week 4 was classified into different categories (i.e., \<=-2.0, \>-2.0 to -1.0, \>-1.0 to 0, \>0 to 1.0, \>1.0 to 2.0, and \>2 g/dL), and the number of participants in each category were summarized., Baseline and Week 4 | Secondary: Hgb Values at the Indicated Time Points, Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer., Up to Week 24|Change From Baseline in Hgb at the Indicated Time Points, Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The Baseline value was the latest pre-dose assessment. Change from Baseline at indicated time-points was calculated by subtracting Baseline value from the post-dose visit value., Baseline and up to Week 24|Number of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL), Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants with Hgb withinthe target range (10.0 to 12.0 g/dL) at each assessment visit was summarized., Up to Week 24|Time to Reach the Lower Target Hgb Level (10.0 g/dL), Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. Participants who could not reach lower target were regarded as censored. The time (in days) to reach the lower target Hgb level (10.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method., Up to Week 24|Number of Participants Who Had Hgb Level of Less Than 7.5 g/dL, Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb level of less than 7.5 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included., Up to Week 24|Number of Participants Who Had Hgb Increase of More Than 2 g/dL Over Any 4 Weeks, Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb increase of more than 2.0 g/dL over any 4 weeks were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included., Up to Week 24|Number of Participants Who Had Hgb Level of More Than 13.0 g/dL, Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb level of more than 13.0 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included., Up to Week 24|Number of Episodes of Achieving Hgb Level of More Than 13.0 g/dL, Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of episodes in participants who had Hgb level of more than 13.0 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included., Up to Week 24|Area Under the Concentration-time Curve (AUC) From Time Zero to 4 Hours (AUC [0-4]) of GSK1278863, Blood samples were collected to evaluate AUC (0-4) at 1, 2, 3 and 4 hours post dose at Weeks 12 and 24. Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Population consisted of all participants who received GSK1278863 with the PK samples collected and analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indiates data was not available. Geometric coefficient of variation could not be calculated when number of participant was equal to 1., 1, 2, 3 and 4 hours post dose at Weeks 12 and 24|Maximum Observed Concentration (Cmax) of GSK1278863, Blood samples were collected to evaluate Cmax at 1, 2, 3 and 4 hours post dose at Weeks 12 and 24. PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indiates data was not available. Geometric coefficient of variation could not be calculated when number of participant was equal to 1., 1, 2, 3 and 4 hours post dose at Weeks 12 and 24|Monthly Average Dose of Intravenous (IV) Iron During the Treatment Period, Records of on-therapy iron medication were used to calculate average quarterly IV iron dose. Quarter 1 = (Randomization Date - Treatment Start Date at Week 12 - 1 \[day\]). Quarter 2 = (Treatment Start Date at Week 12 - Study Treatment Stop Date). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)., Up to Week 24|Number of Participants Who Used Iron During the Treatment Period, The number of participants who used iron (both IV and oral iron) during the treatment period were summarized., Up to Week 24|Change From Baseline in Ferritin, Blood samples were collected from participants for measurement of serum ferritin at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline and up to Week 24|Percent Change From Baseline in TSAT, Blood samples were collected from participants for measurement of TSAT at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1)., Baseline and up to Week 24|Percent Change From Baseline in Hepcidin, Blood samples were collected from participants for measurement of hepcidin at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). If a laboratory value had a non-detectable level reported in the database, where the numeric value was missing, the value was not included in a summary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)., Baseline and up to Week 24|Change From Baseline in Serum Iron, Blood samples were collected from participants for measurement of serum iron at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline and up to Week 24|Change From Baseline in Total Iron Binding Capacity (TIBC), Blood samples were collected from participants for measurement of TIBC at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value., Baseline and up to Week 24|Dose Level of GSK1278863 at Indicated Time Points, Dose adjustment algorithm was used which was based on Hgb values at scheduled visits. Hgb values measured at unscheduled visits were not included. Mean dose during Week 12 to 24 is the average of dose at Weeks 12, 16, and 20., Up to Week 24|Number of Participants With Frequency of Dose Adjustments, Dose adjustment algorithm was used which was based on Hgb values at scheduled visits. Hgb values measured at unscheduled visits were not included. For dose adjustments frequency, the number of participants were provided by the number of dose adjustments (i.e. zero, one, two, three, four, and five or more)., Up to Week 24|Duration of Treatment Interruption Due to Hgb >13 g/dL, Hgb values were used for making decision of treatment interruption. On-therapy Hgb values observed in both scheduled and unscheduled visits were counted. Participants who have no treatment interruption due to Hgb \>13.0 g/dL are not included, Up to Week 24
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| Locations: |
GSK Investigational Site, Aichi, 455-8530, Japan|GSK Investigational Site, Aichi, 457-8511, Japan|GSK Investigational Site, Fukuoka, 802-8555, Japan|GSK Investigational Site, Hokkaido, 065-8611, Japan|GSK Investigational Site, Ibaraki, 300-0028, Japan|GSK Investigational Site, Ibaraki, 302-0022, Japan|GSK Investigational Site, Ibaraki, 306-0433, Japan|GSK Investigational Site, Kagoshima, 891-0105, Japan|GSK Investigational Site, Kumamoto, 861-8520, Japan|GSK Investigational Site, Kyoto, 613-0034, Japan|GSK Investigational Site, Mie, 510-8101, Japan|GSK Investigational Site, Nagano, 392-8510, Japan|GSK Investigational Site, Nagano, 399-8292, Japan|GSK Investigational Site, Oita, 870-0844, Japan|GSK Investigational Site, Osaka, 555-0001, Japan|GSK Investigational Site, Shiga, 523-0082, Japan|GSK Investigational Site, Yamagata, 990-0834, Japan
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