Trial Outcomes & Findings for Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents (NCT NCT02829320)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

28 participants

Primary outcome timeframe

Baseline and Week 4

Results posted on

2019-12-03

Participant Flow

This was a 24-week, Phase 3, open-label, non-comparative, multicenter study to evaluate the efficacy and safety of GSK1278863 in Japanese hemodialysis participants with renal anemia not using Erythropoiesis Stimulating Agents. The study was conducted at 18 centers in Japan from 08-Aug-2016 to 17-Oct-2017.

A total of 36 participants were screened and 8 failed screening because of not meeting eligibility criteria (7) and withdrawal by participants (1). The remaining 28 participants were enrolled in this study. This study consisted of a 4-week screening period, a 24-week treatment period and a 2 to 4-week follow-up period.

Participant milestones

Participant milestones
Measure	All Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 milligram (mg) for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain hemoglobin (Hgb) within the target range (10.0-12.0 grams per deciliter \[g/dL\]). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 nanogram per milliliter (ng/mL) and transferrin saturation (TSAT) is \<=20%.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

All Treated Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Age, Continuous	62.5 Years STANDARD_DEVIATION 10.16 • n=5 Participants • All Treated Subjects
Sex: Female, Male Female	3 Participants n=5 Participants • All Treated Subjects
Sex: Female, Male Male	25 Participants n=5 Participants • All Treated Subjects
Race/Ethnicity, Customized Asian - Japanese Heritage	28 Count of Participants n=5 Participants • All Treated Subjects
Dialysis Status Newly started dialysis	11 Participants n=5 Participants
Dialysis Status Maintenance dialysis	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 4

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Change From Baseline in Hgb at Week 4	0.79 G/dL Interval 0.53 to 1.05	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and Week 4

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Number of Participants by Hgb Change From Baseline Category at Week 4 <= -2.0	0 Participants	—	—	—	—	—	—
Number of Participants by Hgb Change From Baseline Category at Week 4 > -2.0 to -1.0	0 Participants	—	—	—	—	—	—
Number of Participants by Hgb Change From Baseline Category at Week 4 > -1.0 to 0	4 Participants	—	—	—	—	—	—
Number of Participants by Hgb Change From Baseline Category at Week 4 > 0 to 1.0	13 Participants	—	—	—	—	—	—
Number of Participants by Hgb Change From Baseline Category at Week 4 > 1.0 to 2.0	11 Participants	—	—	—	—	—	—
Number of Participants by Hgb Change From Baseline Category at Week 4 > 2.0	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Hgb Values at the Indicated Time Points Day 1	9.10 G/dL Standard Deviation 0.696	—	—	—	—	—	—
Hgb Values at the Indicated Time Points Week 4	9.90 G/dL Standard Deviation 0.907	—	—	—	—	—	—
Hgb Values at the Indicated Time Points Week 8	10.76 G/dL Standard Deviation 0.957	—	—	—	—	—	—
Hgb Values at the Indicated Time Points Week 12	11.09 G/dL Standard Deviation 1.117	—	—	—	—	—	—
Hgb Values at the Indicated Time Points Week 16	11.38 G/dL Standard Deviation 1.286	—	—	—	—	—	—
Hgb Values at the Indicated Time Points Week 20	11.34 G/dL Standard Deviation 1.169	—	—	—	—	—	—
Hgb Values at the Indicated Time Points Week 24	11.12 G/dL Standard Deviation 1.210	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Change From Baseline in Hgb at the Indicated Time Points Week 4	0.79 G/dL Standard Deviation 0.673	—	—	—	—	—	—
Change From Baseline in Hgb at the Indicated Time Points Week 8	1.66 G/dL Standard Deviation 0.773	—	—	—	—	—	—
Change From Baseline in Hgb at the Indicated Time Points Week 12	1.98 G/dL Standard Deviation 0.984	—	—	—	—	—	—
Change From Baseline in Hgb at the Indicated Time Points Week 16	2.28 G/dL Standard Deviation 1.248	—	—	—	—	—	—
Change From Baseline in Hgb at the Indicated Time Points Week 20	2.24 G/dL Standard Deviation 1.174	—	—	—	—	—	—
Change From Baseline in Hgb at the Indicated Time Points Week 24	2.01 G/dL Standard Deviation 1.121	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Number of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) Day 1, within range	3 Participants	—	—	—	—	—	—
Number of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) Week 4, within range	13 Participants	—	—	—	—	—	—
Number of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) Week 8, within range	20 Participants	—	—	—	—	—	—
Number of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) Week 12, within range	18 Participants	—	—	—	—	—	—
Number of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) Week 16, within range	17 Participants	—	—	—	—	—	—
Number of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) Week 20, within range	20 Participants	—	—	—	—	—	—
Number of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) Week 24, within range	23 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Time to Reach the Lower Target Hgb Level (10.0 g/dL)	57.0 Days Interval 29.0 to 57.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Number of Participants Who Had Hgb Level of Less Than 7.5 g/dL	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Number of Participants Who Had Hgb Increase of More Than 2 g/dL Over Any 4 Weeks	1 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Number of Participants Who Had Hgb Level of More Than 13.0 g/dL	3 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Number of Episodes of Achieving Hgb Level of More Than 13.0 g/dL	7 Episodes	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1, 2, 3 and 4 hours post dose at Weeks 12 and 24

Population: PK Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=1 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg n=12 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg n=22 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg n=13 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg n=3 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg n=1 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg n=1 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Area Under the Concentration-time Curve (AUC) From Time Zero to 4 Hours (AUC [0-4]) of GSK1278863 AUC (0-4), Week 12, n=0,4,14,8,1,0,0	—	25.7228 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 289.9	95.1319 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 111.9	200.6036 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 62.9	233.3933 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	—	—
Area Under the Concentration-time Curve (AUC) From Time Zero to 4 Hours (AUC [0-4]) of GSK1278863 AUC (0-4), Week 24, n=1,8,8,5,2,1,1	43.3100 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	33.8941 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 230.9	86.3702 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 58.9	133.3020 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 50.9	437.0983 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 18.7	749.4583 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	126.2883 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1
Area Under the Concentration-time Curve (AUC) From Time Zero to 4 Hours (AUC [0-4]) of GSK1278863 AUC (0-4), All, n=1,12,22,13,3,1,1	43.3100 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	30.9164 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 225.3	91.8474 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 91.1	171.4229 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 60.8	354.6083 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 40.0	749.4583 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	126.2883 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1

SECONDARY outcome

Timeframe: 1, 2, 3 and 4 hours post dose at Weeks 12 and 24

Population: PK Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=1 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg n=12 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg n=22 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg n=13 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg n=3 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg n=1 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg n=1 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Maximum Observed Concentration (Cmax) of GSK1278863 Cmax, Week 12, n=0,4,14,8,1,0,0	—	13.9578 ng/mL Geometric Coefficient of Variation 340.6	57.6572 ng/mL Geometric Coefficient of Variation 81.2	122.9883 ng/mL Geometric Coefficient of Variation 56.9	179.0000 ng/mL Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	—	—
Maximum Observed Concentration (Cmax) of GSK1278863 Cmax, Week 24, n=1,8,8,5,2,1,1	27.5000 ng/mL Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	18.3448 ng/mL Geometric Coefficient of Variation 202.3	44.8853 ng/mL Geometric Coefficient of Variation 49.8	100.2261 ng/mL Geometric Coefficient of Variation 41.3	202.9384 ng/mL Geometric Coefficient of Variation 3.5	311.0000 ng/mL Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	93.4000 ng/mL Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1
Maximum Observed Concentration (Cmax) of GSK1278863 Cmax, All, n=1,12,22,13,3,1,1	27.5000 ng/mL Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	16.7474 ng/mL Geometric Coefficient of Variation 217.4	52.6391 ng/mL Geometric Coefficient of Variation 70.4	113.6784 ng/mL Geometric Coefficient of Variation 50.4	194.6229 ng/mL Geometric Coefficient of Variation 7.7	311.0000 ng/mL Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	93.4000 ng/mL Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

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).

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Monthly Average Dose of Intravenous (IV) Iron During the Treatment Period Quarter 1; n= 3	231.61 Mg Standard Deviation 99.916	—	—	—	—	—	—
Monthly Average Dose of Intravenous (IV) Iron During the Treatment Period Quarter 2; n= 4	217.19 Mg Standard Deviation 86.529	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

The number of participants who used iron (both IV and oral iron) during the treatment period were summarized.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Number of Participants Who Used Iron During the Treatment Period Oral iron	9 Participants	—	—	—	—	—	—
Number of Participants Who Used Iron During the Treatment Period Intravenous iron	4 Participants	—	—	—	—	—	—
Number of Participants Who Used Iron During the Treatment Period Any iron medication	12 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Change From Baseline in Ferritin Week 4	-80.11 Microgram per liter (µg/L) Standard Deviation 51.826	—	—	—	—	—	—
Change From Baseline in Ferritin Week 12	-126.29 Microgram per liter (µg/L) Standard Deviation 120.382	—	—	—	—	—	—
Change From Baseline in Ferritin Week 24	-107.03 Microgram per liter (µg/L) Standard Deviation 143.048	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: All Treated Subjects Population

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).

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Percent Change From Baseline in TSAT Week 4	-23.06 Percentage of transferrin Interval -32.43 to -12.38	—	—	—	—	—	—
Percent Change From Baseline in TSAT Week 12	-15.31 Percentage of transferrin Interval -33.79 to 8.32	—	—	—	—	—	—
Percent Change From Baseline in TSAT Week 24	-10.07 Percentage of transferrin Interval -25.49 to 8.55	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: All Treated Subjects Population

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).

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Percent Change From Baseline in Hepcidin Week 4, n=26	-64.78 Percentage of hepcidin Interval -71.34 to -56.71	—	—	—	—	—	—
Percent Change From Baseline in Hepcidin Week 12, n=22	-61.74 Percentage of hepcidin Interval -74.51 to -42.57	—	—	—	—	—	—
Percent Change From Baseline in Hepcidin Week 24, n=21	-55.67 Percentage of hepcidin Interval -72.52 to -28.47	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Change From Baseline in Serum Iron Week 4	-0.8123 Micromoles per liter (µmol/L) Standard Deviation 4.92624	—	—	—	—	—	—
Change From Baseline in Serum Iron Week 12	2.0916 Micromoles per liter (µmol/L) Standard Deviation 10.74722	—	—	—	—	—	—
Change From Baseline in Serum Iron Week 24	1.4584 Micromoles per liter (µmol/L) Standard Deviation 7.72121	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Change From Baseline in Total Iron Binding Capacity (TIBC) Week 4	8.5904 umol/L Standard Deviation 4.93732	—	—	—	—	—	—
Change From Baseline in Total Iron Binding Capacity (TIBC) Week 12	10.8611 umol/L Standard Deviation 6.32355	—	—	—	—	—	—
Change From Baseline in Total Iron Binding Capacity (TIBC) Week 24	9.3388 umol/L Standard Deviation 9.92131	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

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.

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Dose Level of GSK1278863 at Indicated Time Points Day 1	4.0 mg Interval 4.0 to 4.0	—	—	—	—	—	—
Dose Level of GSK1278863 at Indicated Time Points Week 4	4.0 mg Interval 2.0 to 6.0	—	—	—	—	—	—
Dose Level of GSK1278863 at Indicated Time Points Week 8	4.0 mg Interval 2.0 to 8.0	—	—	—	—	—	—
Dose Level of GSK1278863 at Indicated Time Points Week 12	4.0 mg Interval 0.0 to 8.0	—	—	—	—	—	—
Dose Level of GSK1278863 at Indicated Time Points Week 16	4.0 mg Interval 0.0 to 12.0	—	—	—	—	—	—
Dose Level of GSK1278863 at Indicated Time Points Week 20	4.0 mg Interval 0.0 to 18.0	—	—	—	—	—	—
Dose Level of GSK1278863 at Indicated Time Points Week 12 to 24	4.00 mg Interval 0.0 to 12.7	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

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).

Outcome measures

Outcome measures
Measure	All Participants n=28 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Number of Participants With Frequency of Dose Adjustments Any dose adjustments	21 Participants	—	—	—	—	—	—
Number of Participants With Frequency of Dose Adjustments Number of dose adjustments=0	7 Participants	—	—	—	—	—	—
Number of Participants With Frequency of Dose Adjustments Number of dose adjustments=1	9 Participants	—	—	—	—	—	—
Number of Participants With Frequency of Dose Adjustments Number of dose adjustments=2	7 Participants	—	—	—	—	—	—
Number of Participants With Frequency of Dose Adjustments Number of dose adjustments=3	4 Participants	—	—	—	—	—	—
Number of Participants With Frequency of Dose Adjustments Number of dose adjustments=4	1 Participants	—	—	—	—	—	—
Number of Participants With Frequency of Dose Adjustments Number of dose adjustments=5 or more	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: All Treated Subjects Population

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

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Duration of Treatment Interruption Due to Hgb >13 g/dL	84 Days Interval 28.0 to 84.0	—	—	—	—	—	—

Adverse Events

All Participants

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=28 participants at risk Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Injury, poisoning and procedural complications Shunt occlusion	7.1% 2/28 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until Week 24. On-treatment SAEs and non-serious AEs are reported for All Treated Subjects Population.
Product Issues Device dislocation	3.6% 1/28 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until Week 24. On-treatment SAEs and non-serious AEs are reported for All Treated Subjects Population.

Other adverse events

Other adverse events
Measure	All Participants n=28 participants at risk Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Infections and infestations Nasopharyngitis	32.1% 9/28 • Number of events 10 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until Week 24. On-treatment SAEs and non-serious AEs are reported for All Treated Subjects Population.
Infections and infestations Infected dermal cyst	7.1% 2/28 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until Week 24. On-treatment SAEs and non-serious AEs are reported for All Treated Subjects Population.
Injury, poisoning and procedural complications Shunt stenosis	7.1% 2/28 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until Week 24. On-treatment SAEs and non-serious AEs are reported for All Treated Subjects Population.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	All Participants n=1 Participants Participants with newly started dialysis (dialysis newly started \<12 weeks before screening) or with maintenance dialysis (dialysis started \>=12 weeks before screening) received GSK1278863 orally once daily initially at 4 mg for 4 weeks from Day 1. Subsequently, participants received GSK1278863 orally once a day according to a pre-defined study treatment dose adjustment algorithm to achieve or maintain Hgb within the target range (10.0-12.0 g/dL). In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 2 mg n=12 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 2 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 4 mg n=22 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 4 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 6 mg n=13 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 6 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 8 mg n=3 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 8 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 12 mg n=1 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 12 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.	GSK1278863 18 mg n=1 Participants Participants received GSK1278863 orally once daily initially at 4 mg from Day 1 in 4-week fixed-dose period. Participants received GSK1278863 18 mg orally at specified visits just before collecting the PK samples. As PK samples were collected more than once, participants might be included in more than one arm. In participants taking oral iron before the study, their iron dose was not changed during the fixed-dose period. Supplemental iron therapy was administered if ferritin is \<=100 ng/mL and TSAT is \<=20%.
Area Under the Concentration-time Curve (AUC) From Time Zero to 4 Hours (AUC [0-4]) of GSK1278863 AUC (0-4), Week 12, n=0,4,14,8,1,0,0	—	25.7228 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 289.9	95.1319 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 111.9	200.6036 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 62.9	233.3933 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	—	—
Area Under the Concentration-time Curve (AUC) From Time Zero to 4 Hours (AUC [0-4]) of GSK1278863 AUC (0-4), Week 24, n=1,8,8,5,2,1,1	43.3100 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	33.8941 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 230.9	86.3702 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 58.9	133.3020 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 50.9	437.0983 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 18.7	749.4583 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	126.2883 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1
Area Under the Concentration-time Curve (AUC) From Time Zero to 4 Hours (AUC [0-4]) of GSK1278863 AUC (0-4), All, n=1,12,22,13,3,1,1	43.3100 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	30.9164 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 225.3	91.8474 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 91.1	171.4229 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 60.8	354.6083 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 40.0	749.4583 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1	126.2883 Hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation NA The dispersion was not calculated because of n=1