Trial · NCT02075463
Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia
NCT02075463, Phase 2, Terminated, GlaxoSmithKline; results first posted 2017-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia. Trials, record NCT02075463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02075463
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia
- NCT number
- NCT02075463
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anemia, Anaemia
- Interventions
- GSK1278863, Placebo
- First posted
- 2014-03-03
- Last updated
- 2026-08-04
- Results first posted
- 2017-06-21
- Limitations and caveats
- Due to the study terminating early, resulting in a sparse amount of data, selected parameters were not summarized.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Week 16 | 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 |
| Secondary | Change From Baseline in Hgb Levels at Week 16 | Week 16 | 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. |
| Secondary | Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point | Week 12 to Week 16 | 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. |
| Secondary | Number of Participants Achieving at Least 1 g/dL Increase in Hgb From Baseline at Week 16 | Baseline and Week 16 | 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. |
| Secondary | Number of Participants With Hgb in the Target Range at Week 16 | Week 16 | 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. |
| Secondary | Number of Participants Reaching Pre-defined Hgb Stopping Criteria | Up to Week 16 | 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. |
| Secondary | Percent Change From Baseline in Hepcidin at Week 16 | Baseline (Day 1) and Week 16 | 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. |
| Secondary | Change From Baseline in Ferritin at Week 16 | Baseline (Day 1) and Week 16 | 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. |
| Secondary | Change From Baseline in Transferrin at Week 16 | Baseline (Day 1) and Week 16 | 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. |
| Secondary | Percent Change From Baseline in Transferrin Saturation at Week 16 | Baseline (Day 1) and Week 16 | 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Week 16 | 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 | NUMBER |
| SECONDARY | Change From Baseline in Hgb Levels at Week 16 | Week 16 | ITT population. | g/dL | MEAN |
| SECONDARY | Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point | Week 12 to Week 16 | ITT population. | Percentage of days | MEAN |
| SECONDARY | Number of Participants Achieving at Least 1 g/dL Increase in Hgb From Baseline at Week 16 | Baseline and Week 16 | ITT population. | Participants | NUMBER |
| SECONDARY | Number of Participants With Hgb in the Target Range at Week 16 | Week 16 | ITT population | Participants | NUMBER |
| SECONDARY | Number of Participants Reaching Pre-defined Hgb Stopping Criteria | Up to Week 16 | ITT population | Participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Hepcidin at Week 16 | Baseline (Day 1) and Week 16 | ITT population | Percent change in hepcidin | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Ferritin at Week 16 | Baseline (Day 1) and Week 16 | ITT population | Micrograms/Liter | MEAN |
| SECONDARY | Change From Baseline in Transferrin at Week 16 | Baseline (Day 1) and Week 16 | ITT population | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Transferrin Saturation at Week 16 | Baseline (Day 1) and Week 16 | ITT population | Percent change in transferrin | GEOMETRIC_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group148
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | GSK1278863 12 mg QD | 28.6 | 95% Confidence Interval 8.2 to 64.1 | Percentage of participants | |
| Change From Baseline in Hgb Levels at Week 16 | GSK1278863 12 mg QD | 0.10 | Standard Deviation 1.319 | g/dL | |
| Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point | GSK1278863 12 mg QD | Within Target Range | 48.28 | Standard Deviation 46.102 | Percentage of days |
| Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point | GSK1278863 12 mg QD | Above target range | 0.92 | Standard Deviation 2.605 | Percentage of days |
| Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point | GSK1278863 12 mg QD | Below target range | 50.80 | Standard Deviation 47.176 | Percentage of days |
| Number of Participants Achieving at Least 1 g/dL Increase in Hgb From Baseline at Week 16 | GSK1278863 12 mg QD | 2 | Participants | ||
| Number of Participants With Hgb in the Target Range at Week 16 | GSK1278863 12 mg QD | 2 | Participants | ||
| Number of Participants Reaching Pre-defined Hgb Stopping Criteria | GSK1278863 12 mg QD | 3 | Participants | ||
| Percent Change From Baseline in Hepcidin at Week 16 | GSK1278863 12 mg QD | 16.49 | 95% Confidence Interval -12.14 to 54.43 | Percent change in hepcidin | |
| Change From Baseline in Ferritin at Week 16 | GSK1278863 12 mg QD | -72.1 | Standard Deviation 134.81 | Micrograms/Liter |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK1278863 12 mg QD | 15 | |
| Overall Study | COMPLETED | GSK1278863 12 mg QD | 7 | |
| Overall Study | NOT COMPLETED | GSK1278863 12 mg QD | 8 |
Source ClinicalTrials.gov
Adverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | URINARY TRACT INFECTION | Infections and infestations | GSK1278863 12 mg QD | 2 | 15 | |
| other | GASTROENTERITIS VIRAL | Infections and infestations | GSK1278863 12 mg QD | 1 | 15 | |
| other | INFLUENZA | Infections and infestations | GSK1278863 12 mg QD | 1 | 15 | |
| other | PNEUMONIA | Infections and infestations | GSK1278863 12 mg QD | 1 | 15 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | GSK1278863 12 mg QD | 1 | 15 | |
| other | NAUSEA | Gastrointestinal disorders | GSK1278863 12 mg QD | 3 | 15 | |
| other | VOMITING | Gastrointestinal disorders | GSK1278863 12 mg QD | 1 | 15 | |
| other | BLOOD CALCIUM DECREASED | Investigations | GSK1278863 12 mg QD | 1 | 15 | |
| other | BLOOD PRESSURE INCREASED | Investigations | GSK1278863 12 mg QD | 1 | 15 | |
| other | OCCULT BLOOD POSITIVE | Investigations | GSK1278863 12 mg QD | 1 | 15 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK1278863 12 mg QD | ||
| Total, other adverse events | GSK1278863 12 mg QD | 11 | 15 |
| Total, serious adverse events | GSK1278863 12 mg QD | 9 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29989040 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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