Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia (NCT NCT02075463)
NCT ID: NCT02075463
Last Updated: 2017-06-21
Results Overview
Percentage of participants with increased Hgb \>=1 g/dL (if baseline Hgb is \<9.5 g/dL), or \>=0.5 g/dL (if baseline Hgb is 9.5-\<10 g/dL), or within the target range and not dropped by \>0.5 g/dL (if baseline Hgb is \>= 10 g/dL) at Week 16 are presented. Participants who were available at the indicated time point were analyzed
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Week 16
Results posted on
2017-06-21
Participant Flow
Eligible hemodialysis-dependent participants (par.) with anemia associated with chronic kidney disease and chronically hyporesponsive to recombinant human erythropoietin (rhEPO) (for 12 weeks) were switched from a stable dose of rhEPO
Study consisted of run-in period of 4 weeks (wk), 16-wk Treatment Phase and Follow-up period of 4-wk after completion of treatment.
Participant milestones
| Measure |
GSK1278863 12 mg QD
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Overall Study
STARTED
|
15
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Overall Study
COMPLETED
|
7
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Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
GSK1278863 12 mg QD
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Overall Study
Adverse Event
|
3
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Overall Study
Par. reached stopping criteria
|
4
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia
Baseline characteristics by cohort
| Measure |
GSK1278863 12 mg QD
n=15 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Age, Continuous
|
59.1 Years
STANDARD_DEVIATION 12.76 • n=5 Participants
|
|
Sex: Female, Male
Female
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7 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
WHITE
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13 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 16Population: ITT population: participants who received at least one dose of drug, have a baseline Hgb and at least one corresponding on treatment Hgb assessment.
Percentage of participants with increased Hgb \>=1 g/dL (if baseline Hgb is \<9.5 g/dL), or \>=0.5 g/dL (if baseline Hgb is 9.5-\<10 g/dL), or within the target range and not dropped by \>0.5 g/dL (if baseline Hgb is \>= 10 g/dL) at Week 16 are presented. Participants who were available at the indicated time point were analyzed
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Percentage of Participants Demonstrating an Increase in Hgb of >=1 g/dL (if Baseline Hgb is <9.5 g/dL), or >=0.5 g/dL (if Baseline Hgb is 9.5-<10 g/dL), or Stay Within Target Range and do Not Drop by >0.5 g/dL (if Baseline Hgb is >= 10 g/dL) at Week 16
|
28.6 Percentage of participants
Interval 8.2 to 64.1
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SECONDARY outcome
Timeframe: Week 16Population: ITT population.
Hgb values measured at Week 16 are presented. Change from baseline was calculated as Week 16 minus baseline value . Participants who were available at the indicated time point were analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Change From Baseline in Hgb Levels at Week 16
|
0.10 g/dL
Standard Deviation 1.319
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SECONDARY outcome
Timeframe: Week 12 to Week 16Population: ITT population.
The percentage of time in Hgb levels were in target range (10.0 to 11.5 g/dL) between Weeks 12 and 16 for a participant was calculated by adding the total number of days that Hgb is within target range while on treatment during Weeks 12 to 16 and dividing by the total number of days the participant remained on treatment during Weeks 12 to 16 (using Rosendaal linear interpolation method). Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated. Participants who were available at the indicated time point were analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=8 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point
Within Target Range
|
48.28 Percentage of days
Standard Deviation 46.102
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|
Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point
Above target range
|
0.92 Percentage of days
Standard Deviation 2.605
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|
Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point
Below target range
|
50.80 Percentage of days
Standard Deviation 47.176
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SECONDARY outcome
Timeframe: Baseline and Week 16Population: ITT population.
Number of participants achieving at least 1 g/dL increase in Hgb from baseline at Week 16 were presented. Participants who were available at the indicated time point were analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Number of Participants Achieving at Least 1 g/dL Increase in Hgb From Baseline at Week 16
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2 Participants
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SECONDARY outcome
Timeframe: Week 16Population: ITT population
The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 16 were analyzed. Participants who were available at the indicated time point were analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Number of Participants With Hgb in the Target Range at Week 16
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2 Participants
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SECONDARY outcome
Timeframe: Up to Week 16Population: ITT population
The number of participants who reached the Hgb stopping criteria of Hgb concentration \<7.5 g/dL from baseline to Week 16 were presented. Participants who were available at the indicated time point were analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=15 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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Number of Participants Reaching Pre-defined Hgb Stopping Criteria
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3 Participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: ITT population
Hepcidin is a regulator of iron metabolism. Baseline value for hepcidin is the pre-dose value on Day 1. Percent change was calculated as 100 multiplied by \[exponential (log Week 16 value - log Baseline value) minus 1\]. Participants who were available at the indicated time point were analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Percent Change From Baseline in Hepcidin at Week 16
|
16.49 Percent change in hepcidin
Interval -12.14 to 54.43
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: ITT population
Baseline value for ferritin is the last pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Change From Baseline in Ferritin at Week 16
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-72.1 Micrograms/Liter
Standard Deviation 134.81
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: ITT population
Baseline value for transferrin is the last pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Change From Baseline in Transferrin at Week 16
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0.080 Percent change
Standard Deviation 0.2332
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: ITT population
Transferrin saturation is measured in percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change is 100 times \[exponential (log Week 16 value minus log Baseline value) -1\]. Participants who were available at the indicated time point were analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Percent Change From Baseline in Transferrin Saturation at Week 16
|
18.5 Percent change in transferrin
Interval -21.4 to 78.8
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: ITT population
Baseline value for total iron is the last pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Change From Baseline in Total Iron at Week 16
Participant 1
|
4 Micromoles (µmol)/L
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Change From Baseline in Total Iron at Week 16
Participant 2
|
21 Micromoles (µmol)/L
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Change From Baseline in Total Iron at Week 16
Participant 3
|
-3 Micromoles (µmol)/L
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Change From Baseline in Total Iron at Week 16
Participant 4
|
3 Micromoles (µmol)/L
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Change From Baseline in Total Iron at Week 16
Participant 5
|
2 Micromoles (µmol)/L
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|
Change From Baseline in Total Iron at Week 16
Participant 6
|
5 Micromoles (µmol)/L
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Change From Baseline in Total Iron at Week 16
Participant 7
|
-5 Micromoles (µmol)/L
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SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: ITT population
Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the last pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16
Participant 1
|
14 µmol/ L
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Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16
Participant 2
|
12 µmol/ L
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Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16
Participant 3
|
-6 µmol/ L
|
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Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16
Participant 4
|
-1 µmol/ L
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Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16
Participant 5
|
6 µmol/ L
|
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Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16
Participant 6
|
-4 µmol/ L
|
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Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16
Participant 7
|
8 µmol/ L
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SECONDARY outcome
Timeframe: Week 16Population: Safety population consisted of all participants who received at least one dose of study drug
Data has been presented for only those participants who were available at indicated timepoints
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Reticulocyte Hgb Content (CHr) at Week 16
Participant 1
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38.80 Picogram (pg)
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Reticulocyte Hgb Content (CHr) at Week 16
Participant 2
|
31.50 Picogram (pg)
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Reticulocyte Hgb Content (CHr) at Week 16
Participant 3
|
32.80 Picogram (pg)
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Reticulocyte Hgb Content (CHr) at Week 16
Participant 4
|
30.20 Picogram (pg)
|
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Reticulocyte Hgb Content (CHr) at Week 16
Participant 5
|
31.70 Picogram (pg)
|
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Reticulocyte Hgb Content (CHr) at Week 16
Participant 6
|
30.10 Picogram (pg)
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Reticulocyte Hgb Content (CHr) at Week 16
Participant 7
|
34.30 Picogram (pg)
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SECONDARY outcome
Timeframe: Week 16Population: Safety population
Data has been presented for only those participants who were available at indicated time points.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Mean Corpuscular Volume (MCV) at Week 16
Participant 1
|
124.00 Femtoliter (fL)
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Mean Corpuscular Volume (MCV) at Week 16
Participant 2
|
99.00 Femtoliter (fL)
|
|
Mean Corpuscular Volume (MCV) at Week 16
Participant 3
|
97.00 Femtoliter (fL)
|
|
Mean Corpuscular Volume (MCV) at Week 16
Participant 4
|
101.00 Femtoliter (fL)
|
|
Mean Corpuscular Volume (MCV) at Week 16
Participant 5
|
94.00 Femtoliter (fL)
|
|
Mean Corpuscular Volume (MCV) at Week 16
Participant 6
|
97.00 Femtoliter (fL)
|
|
Mean Corpuscular Volume (MCV) at Week 16
Participant 7
|
106.00 Femtoliter (fL)
|
SECONDARY outcome
Timeframe: Week 16Population: Safety population
Data has been presented for only those participants who were available at indicated time points.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Mean Corpuscular Hemoglobin (MCH) at Week 16
Participant 1
|
39.80 pg
|
|
Mean Corpuscular Hemoglobin (MCH) at Week 16
Participant 2
|
31.30 pg
|
|
Mean Corpuscular Hemoglobin (MCH) at Week 16
Participant 3
|
31.70 pg
|
|
Mean Corpuscular Hemoglobin (MCH) at Week 16
Participant 4
|
31.60 pg
|
|
Mean Corpuscular Hemoglobin (MCH) at Week 16
Participant 6
|
30.70 pg
|
|
Mean Corpuscular Hemoglobin (MCH) at Week 16
Participant 7
|
35.70 pg
|
|
Mean Corpuscular Hemoglobin (MCH) at Week 16
Participant 5
|
30.90 pg
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: ITT population
Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Change From Baseline in Hematocrit at Week 16
Participant 1
|
-0.025 Fraction of 1
|
|
Change From Baseline in Hematocrit at Week 16
Participant 2
|
0.067 Fraction of 1
|
|
Change From Baseline in Hematocrit at Week 16
Participant 3
|
-0.015 Fraction of 1
|
|
Change From Baseline in Hematocrit at Week 16
Participant 4
|
0.043 Fraction of 1
|
|
Change From Baseline in Hematocrit at Week 16
Participant 5
|
-0.016 Fraction of 1
|
|
Change From Baseline in Hematocrit at Week 16
Participant 6
|
0.004 Fraction of 1
|
|
Change From Baseline in Hematocrit at Week 16
Participant 7
|
-0.089 Fraction of 1
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: ITT population
Baseline value for RBC (or erythrocytes) is the last pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
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|---|---|
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Change From Baseline in Red Blood Cell (RBC) at Week 16
Participant 1
|
-0.3 10^12/L
|
|
Change From Baseline in Red Blood Cell (RBC) at Week 16
Participant 2
|
0.7 10^12/L
|
|
Change From Baseline in Red Blood Cell (RBC) at Week 16
Participant 3
|
-0.1 10^12/L
|
|
Change From Baseline in Red Blood Cell (RBC) at Week 16
Participant 4
|
0.3 10^12/L
|
|
Change From Baseline in Red Blood Cell (RBC) at Week 16
Participant 5
|
-0.1 10^12/L
|
|
Change From Baseline in Red Blood Cell (RBC) at Week 16
Participant 6
|
0.2 10^12/L
|
|
Change From Baseline in Red Blood Cell (RBC) at Week 16
Participant 7
|
-0.7 10^12/L
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: ITT population
Baseline value for reticulocyte number is the pre-dose value on Day 1. Change from Baseline in reticulocyte number was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=7 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
|
|---|---|
|
Change From Baseline in Reticulocyte Number at Week 16
Participant 1
|
0.0003 10^12/L
|
|
Change From Baseline in Reticulocyte Number at Week 16
Participant 2
|
0.0043 10^12/L
|
|
Change From Baseline in Reticulocyte Number at Week 16
Participant 3
|
-0.0174 10^12/L
|
|
Change From Baseline in Reticulocyte Number at Week 16
Participant 4
|
-0.0139 10^12/L
|
|
Change From Baseline in Reticulocyte Number at Week 16
Participant 5
|
-0.0201 10^12/L
|
|
Change From Baseline in Reticulocyte Number at Week 16
Participant 6
|
-0.0458 10^12/L
|
|
Change From Baseline in Reticulocyte Number at Week 16
Participant 7
|
-0.0006 10^12/L
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 16Population: ITT population
Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF in the subjects was reported. Baseline value for VEGF is the last pre-dose value on Day 1. Percent change was calculated as 100 multiplied by exponential (log observed maximum value minus log Baseline value) minus 1. Participants who were available at the indicated time point were analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=13 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
|
|---|---|
|
Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)
|
58.72 Percent change
Interval 35.56 to 85.84
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 16Population: ITT population
Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was reported. Baseline value for EPO is the last pre-dose value on Day 1. Change from baseline is calculated as the maximum observed value minus the baseline value. Participants who were available at the indicated time point were analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=13 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
|
|---|---|
|
Maximum Observed Change From Baseline in Erythropoietin (EPO)
|
253.07 international units(IU)/Liter (L)
Standard Deviation 526.670
|
SECONDARY outcome
Timeframe: Up to 16 WeeksPopulation: ITT population
For the first 4 weeks, subjects received 12mg QD of GSK1278863 with dose decrease permitted at Week 2. After 4 weeks of treatment with GSK1278863, need for dose adjustment was evaluated at visits 4, 8 and 12, to maintain hemoglobin within the target range. Target range was defined as: Hgb Criteria of 10.0 to 11.5 g/dL. Data has been presented for only those participants who were available at indicated time points.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=15 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
|
|---|---|
|
Final Dose of GSK1278863
Participant 1
|
25 mg
|
|
Final Dose of GSK1278863
Participant 2
|
12 mg
|
|
Final Dose of GSK1278863
Participant 3
|
25 mg
|
|
Final Dose of GSK1278863
Participant 4
|
8 mg
|
|
Final Dose of GSK1278863
Participant 5
|
12 mg
|
|
Final Dose of GSK1278863
Participant 6
|
15 mg
|
|
Final Dose of GSK1278863
Participant 7
|
10 mg
|
|
Final Dose of GSK1278863
Participant 9
|
0 mg
|
|
Final Dose of GSK1278863
Participant 10
|
12 mg
|
|
Final Dose of GSK1278863
Participant 11
|
12 mg
|
|
Final Dose of GSK1278863
Participant 12
|
15 mg
|
|
Final Dose of GSK1278863
Participant 13
|
15 mg
|
|
Final Dose of GSK1278863
Participant 14
|
15 mg
|
|
Final Dose of GSK1278863
Participant 15
|
25 mg
|
|
Final Dose of GSK1278863
Participant 8
|
12 mg
|
SECONDARY outcome
Timeframe: Day 1, Week 4 and Week 12Population: Pharmacokinetic population
Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose \[PrD\]), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour \[hr\] post-dose \[PoD), and at W12 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed.
Outcome measures
| Measure |
GSK1278863 12 mg QD
n=15 Participants
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
|
|---|---|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531401, W4, 9-15 hr PoD, n=13
|
8.7 ng/mL
Standard Deviation 3.22
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK1278863, D1, PrD, n=15
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK1278863, W4, 6-12 hr PoD, n=13
|
64.8 ng/mL
Standard Deviation 166.48
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK1278863, W4, 7-13 hr PoD, n=13
|
88.6 ng/mL
Standard Deviation 213.55
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK1278863, W4, 8-14 hr PoD, n=13
|
79 ng/mL
Standard Deviation 204.25
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK1278863, W4, 9-15 hr PoD, n=13
|
67.4 ng/mL
Standard Deviation 186.84
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK1278863, W12, PrD, n=8
|
18 ng/mL
Standard Deviation 34.15
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK1278863, W12, 0.5-1 hr PoD, n=8
|
125 ng/mL
Standard Deviation 186.65
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK1278863, W12, 2 hr PoD, n=8
|
103.7 ng/mL
Standard Deviation 140.78
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK1278863, W12, 3 hr PoD, n=8
|
40.6 ng/mL
Standard Deviation 32.53
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2391220, D1, PrD, n=15
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2391220, W4, 6-12 hr PoD, n=13
|
41.3 ng/mL
Standard Deviation 19.16
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2391220, W4, 7-13 hr PoD, n=13
|
22.6 ng/mL
Standard Deviation 10
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2391220, W4, 8-14 hr PoD, n=13
|
16.7 ng/mL
Standard Deviation 8.03
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2391220, W4, 9-15 hr PoD, n=13
|
12.9 ng/mL
Standard Deviation 6.95
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2391220, W12, PrD, n=8
|
25.9 ng/mL
Standard Deviation 22.79
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2391220, W12, 0.5-1 hr PoD, n=8
|
24.9 ng/mL
Standard Deviation 21.63
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2391220, W12, 2 hr PoD, n=8
|
23.7 ng/mL
Standard Deviation 19.94
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2391220, W12, 3 hr PoD, n=8
|
18 ng/mL
Standard Deviation 13.43
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2487818, D1, PrD, n=15
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2487818, W4, 6-12 hr PoD, n=13
|
15.8 ng/mL
Standard Deviation 11.02
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2487818, W4, 7-13 hr PoD, n=13
|
9.3 ng/mL
Standard Deviation 6.1
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2487818, W4, 8-14 hr PoD, n=13
|
7.2 ng/mL
Standard Deviation 4.96
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2487818, W4, 9-15 hr PoD, n=13
|
5.8 ng/mL
Standard Deviation 4.97
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2487818, W12, PrD, n=8
|
6.5 ng/mL
Standard Deviation 9.01
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2487818, W12, 0.5-1 hr PoD, n=8
|
10.6 ng/mL
Standard Deviation 10.87
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2487818, W12, 2 hr PoD, n=8
|
15.6 ng/mL
Standard Deviation 19.22
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2487818, W12, 3 hr PoD, n=8
|
11.6 ng/mL
Standard Deviation 11.17
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2506102, D1, PrD, n=15
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2506102, W4, 6-12 hr PoD, n=13
|
13.6 ng/mL
Standard Deviation 6.55
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2506102, W4, 7-13 hr PoD, n=13
|
7.5 ng/mL
Standard Deviation 3.34
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2506102, W4, 8-14 hr PoD, n=13
|
5.6 ng/mL
Standard Deviation 2.6
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2506102, W4, 9-15 hr PoD, n=13
|
4.3 ng/mL
Standard Deviation 2.24
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2506102, W12, PrD, n=8
|
10 ng/mL
Standard Deviation 7.54
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2506102, W12, 0.5-1 hr PoD, n=8
|
7.9 ng/mL
Standard Deviation 6.53
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2506102, W12, 2 hr PoD, n=8
|
6.3 ng/mL
Standard Deviation 4.14
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2506102, W12, 3 hr PoD, n=8
|
4.9 ng/mL
Standard Deviation 3.2
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531398, D1, PrD, n=15
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531398, W4, 6-12 hr PoD, n=13
|
16.6 ng/mL
Standard Deviation 9.12
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531398, W4, 7-13 hr PoD, n=13
|
9.4 ng/mL
Standard Deviation 4.98
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531398, W4, 8-14 hr PoD, n=13
|
7.1 ng/mL
Standard Deviation 4.04
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531398, W4, 9-15 hr PoD, n=13
|
5.6 ng/mL
Standard Deviation 3.5
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531398, W12, PrD, n=8
|
8.2 ng/mL
Standard Deviation 7.78
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531398, W12, 0.5-1 hr PoD, n=8
|
8.5 ng/mL
Standard Deviation 7.57
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531398, W12, 2 hr PoD, n=8
|
9.3 ng/mL
Standard Deviation 8.71
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531398, W12, 3 hr PoD, n=8
|
7.3 ng/mL
Standard Deviation 5.75
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531401, D1, PrD, n=15
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531401, W4, 6-12 hr PoD, n=13
|
28.4 ng/mL
Standard Deviation 11.94
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531401, W4, 7-13 hr PoD, n=13
|
15.6 ng/mL
Standard Deviation 5.64
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531401, W4, 8-14 hr PoD, n=13
|
11.6 ng/mL
Standard Deviation 4.43
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531401, W12, PrD, n=8
|
27.8 ng/mL
Standard Deviation 22.34
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531401, W12, 0.5-1 hr PoD, n=8
|
21 ng/mL
Standard Deviation 19.46
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531401, W12, 2 hr PoD, n=8
|
14.6 ng/mL
Standard Deviation 11.05
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531401, W12, 3 hr PoD, n=8
|
11.2 ng/mL
Standard Deviation 8.83
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531403, D1, PrD, n=15
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531403, W4, 6-12 hr PoD, n=13
|
51.8 ng/mL
Standard Deviation 22.75
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531403, W4, 7-13 hr PoD, n=13
|
28.2 ng/mL
Standard Deviation 11.85
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531403, W4, 8-14 hr PoD, n=13
|
20.6 ng/mL
Standard Deviation 9.34
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531403, W4, 9-15 hr PoD, n=13
|
15.8 ng/mL
Standard Deviation 8.07
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531403, W12, PrD, n=8
|
35.8 ng/mL
Standard Deviation 28.09
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531403, W12, 0.5-1 hr PoD, n=8
|
30.6 ng/mL
Standard Deviation 25.2
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531403, W12, 2 hr PoD, n=8
|
25.7 ng/mL
Standard Deviation 18.15
|
|
Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points
GSK2531403, W12, 3 hr PoD, n=8
|
19.6 ng/mL
Standard Deviation 13.14
|
Adverse Events
GSK1278863 12 mg QD
Serious events: 9 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1278863 12 mg QD
n=15 participants at risk
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
|
|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
CARDIAC ARREST
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
PNEUMONIA
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
PNEUMONIA MYCOPLASMAL
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL STOMA COMPLICATION
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
PROCEDURAL HAEMORRHAGE
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
HAEMATOMA
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
SHOCK
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
GSK1278863 12 mg QD
n=15 participants at risk
Participants received a fixed dose GSK1278863 12 milligram (mg) once daily (QD) for the first 4 weeks. After Week 4, the dose was adjusted every four weeks to achieve hemoglobin (Hgb) levels within the range of 10.0-11.5 grams (g)/deciliter (dL); however, a dose decrease was also permitted for a subject at Week 2 if the rise in Hgb is too rapid.
|
|---|---|
|
Infections and infestations
URINARY TRACT INFECTION
|
13.3%
2/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
INFLUENZA
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
PNEUMONIA
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
20.0%
3/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
BLOOD CALCIUM DECREASED
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Investigations
OCCULT BLOOD POSITIVE
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
FATIGUE
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
General disorders
PYREXIA
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
ARTERIOVENOUS FISTULA SITE COMPLICATION
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
ARTERIOVENOUS FISTULA THROMBOSIS
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
13.3%
2/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
BRACHIOCEPHALIC VEIN STENOSIS
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
VENOUS STENOSIS
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
SINUS HEADACHE
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
6.7%
1/15 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up (up to 20 weeks).
On-treatment SAEs and non-serious AEs were reported for the Safety population consisted of all participants who received at least one dose of study drug.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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