| Outcome Measures: |
Primary: Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52), The mean hemoglobin during the Evaluation Period was estimated by a statistical model., Weeks 40 to 52 | Secondary: Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52), The percentage of participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Odds ratio was estimated using a logistic regression and provided along with its 95% CI and a one-sided p-value., Weeks 40 to 52|Change From Baseline in Hgb (Hgb Increase Rate) at Week 4, Change from Baseline was calculated as the post-dose Week 4 visit value minus the Baseline value., Baseline and Week 4|Percentage of Participants by Hgb Change From Baseline Category at Week 4, Percentage of participants within each category were provided only for daprodustat and the categories were classified into 6 (i.e., \<=-2, \>-2 to -1, \>-1 to 0, \>0 to 1, \>1 to 2, \>2 grams per deciliter \[g/dL\]). In addition, 'within 1.0 g/dL (i.e., \<=-1 and \>=1) and over 2.0 g/dL (i.e., \<-2 and \>2) categories were provided., Week 4|Distribution of Daprodustat Dose Level by Visit, Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Daprodustat. Median along with the interquartile range (25th and 75th percentile) has been presented., Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44, and 48)|Distribution of Darbepoetin Alfa Dose Level by Visit, Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Darbepoetin Alfa. Median along with the interquartile range (25th and 75th percentile) has been presented., Day 1, Weeks 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48, and 50|Duration of Treatment Interruption Due to Hgb >13 g/dL, Duration of treatment interruption due to Hgb \>13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for the daprodustat group., Up to Week 52|Number of Dose Adjustments for Daprodustat, Number of dose adjustments has been presented only for daprodustat., Up to Week 52|Hgb Values at Each Assessment Visit, Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented., Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|Change From Baseline in Hgb Values at Each Assessment Visit, Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calcuated as the post-dose visit value minus the Baseline value. Change from Baseline Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented., Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|Percentage of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) at Each Assessment Visit, Percentage of participants with Hgb within the target range was summarized at each assessment visit by treatment group have been presented., Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|Percentage of Time in Hgb Target Range (10.0 to 12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52), Percentage of time in Hgb target range (10.0 to 12.0 g/dL) during the primary efficacy evaluation period (Weeks 40 to 52) for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented., Weeks 40 to 52|Number of Participants Who Had an Hgb Level of Less Than 7.5 g/dL, If an initial Hgb value was less than 7.5 g/dL, measurement was repeated at the same study visit (using the same sample) to calculate the average. If the average met the Hgb stopping criteria, study treatment was permanently discontinued. Number of participants who had an Hgb level of less than 7.5 g/dL has been presented., Up to Week 52|Number of Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks, Number of participants who had an Hgb increase of more than 2 g/dL over any 4 weeks for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented., Up to Week 52|Number of Participants Who Had an Hgb Level of More Than 13.0 g/dL, Number of participants who had an Hgb increase of more than 13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented., Up to Week 52|Number of Episodes With Hgb Level of More Than 13.0 g/dL, Number of episodes with Hgb level of more than 13.0 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented., Up to Week 52|Area Under Plasma Concentration Curve From Time Zero to 4 Hours (AUC [0 - 4]) of Plasma Daprodustat, Blood samples for Pharmacokinetic (PK) analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). NA indicates geometric co-efficient of variation could not be calculated as a single participant was analyzed. Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. PK population comprised of all daprodustat-treated participants from whom PK samples were collected and analyzed. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data., 0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24|Maximum Concentration (Cmax) of Plasma Daprodustat, Blood samples for PK analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data., 0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24
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| Locations: |
GSK Investigational Site, Aichi, 441-8023, Japan|GSK Investigational Site, Aichi, 446-0053, Japan|GSK Investigational Site, Aichi, 446-0065, Japan|GSK Investigational Site, Aichi, 454-0932, Japan|GSK Investigational Site, Aichi, 455-0021, Japan|GSK Investigational Site, Aichi, 462-0802, Japan|GSK Investigational Site, Aichi, 486-8510, Japan|GSK Investigational Site, Chiba, 276-0031, Japan|GSK Investigational Site, Ehime, 790-0962, Japan|GSK Investigational Site, Ehime, 792-0812, Japan|GSK Investigational Site, Fukui, 918-8503, Japan|GSK Investigational Site, Fukuoka, 804-0094, Japan|GSK Investigational Site, Fukuoka, 811-0120, Japan|GSK Investigational Site, Fukuoka, 811-0213, Japan|GSK Investigational Site, Fukuoka, 818-0083, Japan|GSK Investigational Site, Fukushima, 963-8002, Japan|GSK Investigational Site, Fukushima, 963-8071, Japan|GSK Investigational Site, Gunma, 370-0615, Japan|GSK Investigational Site, Gunma, 372-0817, Japan|GSK Investigational Site, Gunma, 375-0024, Japan|GSK Investigational Site, Hokkaido, 004-0814, Japan|GSK Investigational Site, Hokkaido, 007-0803, Japan|GSK Investigational Site, Hokkaido, 073-0022, Japan|GSK Investigational Site, Hokkaido, 073-0196, Japan|GSK Investigational Site, Ibaraki, 300-0062, Japan|GSK Investigational Site, Ibaraki, 302-0011, Japan|GSK Investigational Site, Ibaraki, 305-0861, Japan|GSK Investigational Site, Kagawa, 761-8024, Japan|GSK Investigational Site, Kanagawa, 224-0032, Japan|GSK Investigational Site, Kanagawa, 227-0046, Japan|GSK Investigational Site, Kanagawa, 234-0054, Japan|GSK Investigational Site, Kanagawa, 235-0045, Japan|GSK Investigational Site, Kyoto, 613-0034, Japan|GSK Investigational Site, Miyagi, 981-0954, Japan|GSK Investigational Site, Nagano, 390-0821, Japan|GSK Investigational Site, Nagano, 390-1401, Japan|GSK Investigational Site, Nagano, 399-8292, Japan|GSK Investigational Site, Okayama, 714-0043, Japan|GSK Investigational Site, Osaka, 543-0052, Japan|GSK Investigational Site, Osaka, 547-0024, Japan|GSK Investigational Site, Osaka, 584-0082, Japan|GSK Investigational Site, Osaka, 594-0076, Japan|GSK Investigational Site, Saitama, 348-0045, Japan|GSK Investigational Site, Shizuoka, 424-0012, Japan|GSK Investigational Site, Tokyo, 158-0094, Japan|GSK Investigational Site, Tokyo, 169-0075, Japan|GSK Investigational Site, Toyama, 930-0065, Japan|GSK Investigational Site, Toyama, 938-8502, Japan|GSK Investigational Site, Yamagata, 990-0834, Japan|GSK Investigational Site, Yamaguchi, 755-0155, Japan
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