Trial · NCT01977482
Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia
NCT01977482, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia. Trials, record NCT01977482. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01977482
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia
- NCT number
- NCT01977482
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 216 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- GSK1278863, Placebo, rhEPO
- First posted
- 2013-11-06
- Last updated
- 2018-06-08
- Results first posted
- 2017-02-14
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin (Hgb) at Week 4 | Baseline (Week -4, Week-2 and Day 1) and Week 4 | Baseline Hgb value was the average of three Hgb values taken during screening period at Week (W) -4, W-2 and Day 1. Change from Baseline in Hgb was calculated as W4 value minus the Baseline value. To model the dose-response relationship a four-parameter Emax model was used. The dose response dataset was based on all non-missing data collected up to W4. Participants (par.) who had a Week 2 Hgb measurement, but a missing Week 4 Hgb measurement were included with a change from Baseline at Week 4 value imputed as twice the change from Baseline at Week 2. E0 is the expected Hgb change from Baseline for a par. receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a par. receiving the highest dose above which no further increase in response can be achieved. ED50 is the dose that attains the intermediate response. Gamma is the slope parameter. Alpha is the coefficient of the model covariate for centred Baseline. |
| Secondary | Hgb Concentration at Week 24 | Week 24 | Hgb values measured at Week 24 are presented. |
| Secondary | Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24 | Week 20 to Week 24 | The percentage of time in Hgb target range between Weeks 20 and 24 for a participant was calculated by dividing the total number of days that Hgb was within the target range (10.0 to 11.5 g/dL) while on treatment during Weeks 20 to 24 (using linear interpolation) by the total number of days the participant remained on treatment during the defined period. Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated. |
| Secondary | Number of Participants With Hgb in the Target Range at Week 24 | Week 24 | The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 24 was recorded for each arm. |
| Secondary | Number of Participants Reaching Pre-defined Hgb Stopping Criteria | Up to 24 weeks | The number of participants who reached the Hgb stopping criteria of Hgb concentration \<7.5 g/dL were presented. |
| Secondary | Maximum Observed Change From Baseline in Erythropoietin (EPO) | Baseline (Day 1) to Week 28 | Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (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-dose values minus the Baseline value. |
| Secondary | Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF) | Baseline (Day 1) to Week 28 | Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (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 percent change from Baseline in VEGF was recorded for each arm. Baseline value for VEGF is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1. |
| Secondary | Population Plasma PK Parameters of GSK1278863 and Metabolites | Day 1, Week 4, and Week 20 | 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 W20 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed. |
| Secondary | Percent Change From Baseline in Hepcidin at Week 24 | Baseline (Day 1) and Week 24 | Hepcidin is a regulator of iron metabolism. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1. |
| Secondary | Change From Baseline in Ferritin at Week 24 | Baseline (Day 1) and Week 24 | Baseline value for ferritin is the pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 24 value minus the Baseline value. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hemoglobin (Hgb) at Week 4 | Baseline (Week -4, Week-2 and Day 1) and Week 4 | ITT Population. Only participants with data available at specific time point were analyzed. | grams (g)/deciliter (dL) | MEAN |
| SECONDARY | Hgb Concentration at Week 24 | Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | g/dL | MEAN |
| SECONDARY | Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24 | Week 20 to Week 24 | ITT population. Only participants with data available at specific timepoint were analyzed. | Percentage of days | MEAN |
| SECONDARY | Number of Participants With Hgb in the Target Range at Week 24 | Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Reaching Pre-defined Hgb Stopping Criteria | Up to 24 weeks | ITT Population | Participants | NUMBER |
| SECONDARY | Maximum Observed Change From Baseline in Erythropoietin (EPO) | Baseline (Day 1) to Week 28 | ITT Population. Only participants with data available at specific time point were analyzed. | international units(IU)/Liter (L) | MEAN |
| SECONDARY | Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF) | Baseline (Day 1) to Week 28 | ITT Population. Only participants with data available at specific time point were analyzed. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Population Plasma PK Parameters of GSK1278863 and Metabolites | Day 1, Week 4, and Week 20 | Pharmacokinetic Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the pharmacokinetic population | nanograms (ng)/milliliter (mL) | MEAN |
| SECONDARY | Percent Change From Baseline in Hepcidin at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Ferritin at Week 24 | Baseline (Day 1) and Week 24 | ITT Population. Only participants with data available at specific time point were analyzed. | Micrograms/Liter | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group429
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hemoglobin (Hgb) at Week 4 | Control | -0.64 | Standard Deviation 0.829 | grams (g)/deciliter (dL) | |
| Change From Baseline in Hemoglobin (Hgb) at Week 4 | GSK1278863 4 mg | -0.24 | Standard Deviation 0.989 | grams (g)/deciliter (dL) | |
| Change From Baseline in Hemoglobin (Hgb) at Week 4 | GSK1278863 6 mg | 0.08 | Standard Deviation 1.131 | grams (g)/deciliter (dL) | |
| Change From Baseline in Hemoglobin (Hgb) at Week 4 | GSK1278863 8 mg | 0.42 | Standard Deviation 0.796 | grams (g)/deciliter (dL) | |
| Change From Baseline in Hemoglobin (Hgb) at Week 4 | GSK1278863 10 mg | 0.64 | Standard Deviation 1.177 | grams (g)/deciliter (dL) | |
| Change From Baseline in Hemoglobin (Hgb) at Week 4 | GSK1278863 12 mg | 0.61 | Standard Deviation 1.245 | grams (g)/deciliter (dL) | |
| Hgb Concentration at Week 24 | Control | 10.56 | Standard Deviation 0.974 | g/dL | |
| Hgb Concentration at Week 24 | GSK1278863 4 mg | 10.29 | Standard Deviation 0.864 | g/dL | |
| Hgb Concentration at Week 24 | GSK1278863 6 mg | 10.54 | Standard Deviation 1.010 | g/dL | |
| Hgb Concentration at Week 24 | GSK1278863 8 mg | 10.63 | Standard Deviation 1.099 | g/dL |
1 to 10 of 429Source ClinicalTrials.gov
See all 429 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control | 39 | |
| Overall Study | STARTED | GSK1278863 4 mg | 39 | |
| Overall Study | STARTED | GSK1278863 6 mg | 40 | |
| Overall Study | STARTED | GSK1278863 8 mg | 39 | |
| Overall Study | STARTED | GSK1278863 10 mg | 40 | |
| Overall Study | STARTED | GSK1278863 12 mg | 19 | |
| Overall Study | COMPLETED | Control | 36 | |
| Overall Study | COMPLETED | GSK1278863 4 mg | 30 | |
| Overall Study | COMPLETED | GSK1278863 6 mg | 35 | |
| Overall Study | COMPLETED | GSK1278863 8 mg | 35 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events660
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 | Anaemia | Blood and lymphatic system disorders | Control | 0 | 39 | |
| other | Anaemia | Blood and lymphatic system disorders | GSK1278863 4 mg | 2 | 39 | |
| other | Anaemia | Blood and lymphatic system disorders | GSK1278863 6 mg | 2 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | GSK1278863 8 mg | 1 | 39 | |
| other | Anaemia | Blood and lymphatic system disorders | GSK1278863 10 mg | 0 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | GSK1278863 12 mg | 0 | 19 | |
| other | Cataract | Eye disorders | Control | 0 | 39 | |
| other | Cataract | Eye disorders | GSK1278863 4 mg | 2 | 39 | |
| other | Cataract | Eye disorders | GSK1278863 6 mg | 1 | 40 | |
| other | Cataract | Eye disorders | GSK1278863 8 mg | 1 | 39 |
1 to 10 of 660Source ClinicalTrials.gov
See all 660 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | ||
| Total, all-cause mortality | GSK1278863 4 mg | ||
| Total, all-cause mortality | GSK1278863 6 mg | ||
| Total, all-cause mortality | GSK1278863 8 mg | ||
| Total, all-cause mortality | GSK1278863 10 mg | ||
| Total, all-cause mortality | GSK1278863 12 mg | ||
| Total, other adverse events | Control | 17 | 39 |
| Total, other adverse events | GSK1278863 4 mg | 28 | 39 |
| Total, other adverse events | GSK1278863 6 mg | 17 | 40 |
| Total, other adverse events | GSK1278863 8 mg | 25 | 39 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36005278 | DERIVED |
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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