A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)
CompletedPhase 2Results postedLast updated 12 October 2018
What this trial tests
Phase 2 trial testing GSK1278863 in Anaemia in 252 participants. Completed in 15 June 2015.
Adults 18 to 99, any sex, with Anaemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Summary of Hemoglobin (Hgb) Concentration at Week 24Primary· Week 24
The original Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-10.0 g/dL (8.0-10.0 g/dL USA site only) and for Group 2- rhEPO users with a stable baseline Hgb of 9.0-10.5 g/dL (9.0-10.5 g/dL USA site only); the Hgb target range was 9.0 to 10.5 g/dL (9.0-10.5 g/dL USA site only). The study amended Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-11.0 g/dL and Group 2- rhEPO users with a stable baseline Hgb of 9.0-11.5 g/dL; Hgb target range - 10.0 to 11.5 g/dL. Data are presented for those participants following the original
Original n=45,15,19,13
Group
Value
95% CI
rhEPO-Naive GSK1278863
10.20
± 0.906
rhEPO-Naive Control
10.64
± 0.664
rhEPO-User GSK1278863
10.03
± 0.522
rhEPO-User Control
10.66
± 0.620
Amended n=61,21,11,17
Group
Value
95% CI
rhEPO-Naive GSK1278863
10.96
± 1.044
rhEPO-Naive Control
11.05
± 1.144
rhEPO-User GSK1278863
10.42
± 0.827
rhEPO-User Control
10.86
± 1.182
Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24Secondary· Week 24
Target range is defined as: Original Hgb Criteria of 9.0 to 10.5 gram/deciliter (g/dL), and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.
Group
Value
95% CI
rhEPO-Naive GSK1278863
78
rhEPO-Naive Control
20
rhEPO-User GSK1278863
22
rhEPO-User Control
19
Number of Participants Reaching Pre-defined Hgb Stopping CriteriaSecondary· Over a period of 24 Weeks
The Hgb stopping criteria was a value of \<7.5 mg/dL obtained on-site via a validated point-of-care Hgb measurement device, which necessitated permanent discontinuation of the study medication. None of the participants met the stopping criteria therefore there is no data to present for this outcome measure.
Group
Value
95% CI
rhEPO-Naive GSK1278863
0
rhEPO-Naive Control
0
rhEPO-User GSK1278863
0
rhEPO-User Control
0
Percent Change From Baseline in Hepcidin Concentration at Week 24Secondary· Baseline and Week 24
Baseline is the last pre-dose hepcidin value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the Week 24 value.
Group
Value
95% CI
rhEPO-Naive GSK1278863
-19.27
-28.10 – -9.36
rhEPO-Naive Control
6.67
-13.62 – 31.72
rhEPO-User GSK1278863
-9.87
-28.59 – 13.76
rhEPO-User Control
-17.12
-33.22 – 2.86
Maximum Observed Change From Baseline in Serum Erythropoietin (EPO)Secondary· Baseline to Week 24
Blood samples for control arm were collected pre-dose for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-baselin
Group
Value
95% CI
rhEPO-Naive GSK1278863
7.27
± 12.744
rhEPO-Naive Control
27.05
± 94.999
rhEPO-User GSK1278863
3.69
± 20.554
rhEPO-User Control
25.85
± 38.890
Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)Secondary· Baseline and up to Week 24
Blood samples for control arm were collected pre-dose for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for VEGF measurement. The maximum observed change from baseline in VEGF was recorded for each arm . Baseline value for VEGF is the pre-dose value on Day 1. Change from Baseline in VEGF was calculated as the individual post-b
Group
Value
95% CI
rhEPO-Naive GSK1278863
76.36
59.46 – 95.06
rhEPO-Naive Control
26.84
1.73 – 58.15
rhEPO-User GSK1278863
49.99
28.28 – 75.39
rhEPO-User Control
40.85
19.14 – 66.52
Percentage of Time Within, Below, and Above Hemoglobin (Hgb) Target Range, Between Weeks 12 and 24Secondary· Weeks 12 to 24
The number of days a participant's Hgb was within target range was calculated by estimating (using linear interpolation) the number of days within target range between two scheduled Hgb visits. Percentage of time within range for a participant was calculated by dividing the total number of days that Hgb was within range during Weeks 12 to 24 by the total number of days the participant remained on treatment during Weeks 12 to 24. Similary, percent of time above and below Hgb target range was calculated. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Crit
Percentage of time within target range
Group
Value
95% CI
rhEPO-Naive GSK1278863
68.99
± 34.612
rhEPO-Naive Control
51.01
± 41.403
rhEPO-User GSK1278863
75.06
± 32.485
rhEPO-User Control
61.29
± 43.352
Percentage of time above target range
Group
Value
95% CI
rhEPO-Naive GSK1278863
22.84
± 33.825
rhEPO-Naive Control
45.10
± 42.579
rhEPO-User GSK1278863
17.96
± 28.809
rhEPO-User Control
31.10
± 41.683
Percentage of time below target range
Group
Value
95% CI
rhEPO-Naive GSK1278863
8.17
± 20.301
rhEPO-Naive Control
3.89
± 16.175
rhEPO-User GSK1278863
6.98
± 21.118
rhEPO-User Control
7.61
± 25.113
Change From Baseline in Ferritin Concentration at Week 24Secondary· Baseline and Week 24
Baseline is the last pre-dose ferritin value. Change was calculated by subtracting the Baseline value from the Week 24 value.
Group
Value
95% CI
rhEPO-Naive GSK1278863
-30.8
± 110.50
rhEPO-Naive Control
-2.4
± 77.06
rhEPO-User GSK1278863
-63.4
± 141.93
rhEPO-User Control
-20.4
± 63.38
Change From Baseline in Transferrin Concentration at Week 24Secondary· Baseline and Week 24
Baseline is the last pre-dose transferrin value. Change from Baseline in transferrin was calculated by subtracting the Baseline value from the Week 24 value.
Group
Value
95% CI
rhEPO-Naive GSK1278863
0.077
± 0.3577
rhEPO-Naive Control
-0.008
± 0.2694
rhEPO-User GSK1278863
0.171
± 0.4124
rhEPO-User Control
0.018
± 0.2395
Percent Change From Baseline in Transferrin Saturation at Week 24Secondary· Baseline and Week 24
Transferrin saturation is measured as a percentage; it is a ratio of serum iron and total iron-binding capacity. Baseline is the last pre-dose transferrin saturation value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the post-dose value.
Group
Value
95% CI
rhEPO-Naive GSK1278863
-1.1
-8.0 – 6.4
rhEPO-Naive Control
12.3
2.2 – 23.3
rhEPO-User GSK1278863
-15.7
-26.8 – -3.0
rhEPO-User Control
11.4
-14.7 – 45.6
Change From Baseline in Total Iron at Week 24Secondary· Baseline and Week 24
Baseline is the last pre-dose total iron value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.
Group
Value
95% CI
rhEPO-Naive GSK1278863
1.0
± 5.01
rhEPO-Naive Control
2.5
± 5.98
rhEPO-User GSK1278863
-1.8
± 5.54
rhEPO-User Control
0.7
± 8.36
Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 24Secondary· Baseline and Week 24
TIBC measures the blood's capacity to bind iron with transferrin. Baseline is the last pre-dose TIBC value. Change from Baseline in TIBC was calculated by subtracting the Baseline value from the Week 24 value.
Group
Value
95% CI
rhEPO-Naive GSK1278863
3.2
± 6.46
rhEPO-Naive Control
0.1
± 5.17
rhEPO-User GSK1278863
3.0
± 9.44
rhEPO-User Control
-1.0
± 6.69
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until the follow-up contact (up to 28 weeks)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02829320 — Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Dis
· Phase 3
· completed
NCT02689206 — Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of GSK1278863 in Hemodialysis-d
· Phase 2
· completed
NCT02243306 — Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialys
· Phase 1
· completed
NCT02075463 — Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemod
· Phase 2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 12 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01977573.