Trial · NCT02019719
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease
NCT02019719, Phase 2, Completed, GlaxoSmithKline; results first posted 2018-02-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease. Trials, record NCT02019719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02019719
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Japanese Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease
- NCT number
- NCT02019719
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 97 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- GSK1278863, Placebo
- First posted
- 2013-12-24
- Last updated
- 2018-02-12
- Results first posted
- 2018-02-12
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 (CFB) in Hemaglobin (Hgb) at Week 4 | Baseline (Day 1) and Week 4 | Baseline was defined as the value on Day 1. CFB was calculated by subtracting the baseline value from the post-dose value at Week 4. To model the dose-response relationship a four-parameter Emax model was used. E0 is the expected Hgb change from Baseline for a participant receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a participant 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. Minimal Effective Dose (MED) is defined as the smallest dose that achieves a placebo-corrected change of 0.5 g/dL over Week 4. Target dose (TD) is defined as the dose that achieves a placebo-corrected 1.0 g/dL change over Week 4. Maximum Acceptable Dose (MAD) is defined as the dose that achieves a placebo-corrected 2.0 g/dL change over Week 4. |
| Secondary | CFB in Hgb Upto Week 8 | Baseline (Day 1) Upto Week 8 | Hgb assessments were performed at Baseline, Week 1, Week 2, Week 3, W eek4/Early withdrawal and Week 8 (follow-up) based on central laboratory (Quest diagnosis). Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4. |
| Secondary | Number of Participants Who Achieved Hgb Response at Week 4 | Week 4 | Hgb response was defined as achieving an increase of at least 0.5 g/dL, 1.0 g/dL, 1.5 g/dL, and 2.0 g/dL in Hgb. The number of participants with Hgb response: Hgb increase \<-1.0, Hgb increase -1.0 -\< -0.5, Hgb increase -0.5 -\< 0.5, Hgb increase 0.5 -\< 1.0 and Hgb increase \>=1.0 have been presented. |
| Secondary | Percentage of Participants Who Achieved Hgb Response at Week 4 | Week 4 | Hgb response was defined as achieving an increase of at least 0.5 g/dL, 1.0 g/dL, 1.5 g/dL, and 2.0 g/dL in Hgb. The percentage of participants with Hgb response: Hgb increase \<-1.0, Hgb increase -1.0 -\< -0.5, Hgb increase -0.5 -\< 0.5, Hgb increase 0.5 -\< 1.0 and Hgb increase \>=1.0 have been presented. |
| Secondary | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | Upto Week 4 | Hgb stopping criteria was defined as: (1) Hgb \<7.5 g/dL (2) 7.5 \<= Hgb \<1 3.0 g/dL and \>2 g/dL Hgb change over 2W (3) Hgb \>=13.0 g/dL. The number of participants who reached pre-defined Hgb stopping criteria have been presented. |
| Secondary | Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4 | Baseline (Day 1) Upto Week 4 | Blood samples for EPO were collected on Day 1 (pre-dose), Week 2 (collected approx 6-12 hours post-dose on arrival and after 1, 2 and 3 hours) and Week 4 (pre-dose and 3 hours post-dose). Maximum observed value meant maximum value between Week 1 and Week 4. Baseline was defined as the value on Day 1. Maximum observed CFB was calculated by subtracting the Baseline value from the maximum observed value between Week 1 and Week 4. |
| Secondary | Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4 | Baseline (Day 1) Upto Week 4 | Blood samples for VEGF were collected on Day 1 (pre-dose), Week 2 (collected approximately 6-12 hours post-dose on arrival and after 1, 2 and 3 hours) and Week 4 (pre-dose and 3 hours post-dose). Maximum observed value meant maximum value between Week 1 and Week 4. Baseline was defined as the value on Day 1. Maximum observed percent CFB was calculated as 100 multiplied by the maximum observed exponential mean change on a log scale minus 1. |
| Secondary | Percent CFB in Hepcidine Upto Week 4 | Baseline (Day 1) Upto Week 4 | Blood samples for hepcidine were collected on Day 1 (pre-dose), Week 2 (collected approximately 6-12 hours post-dose) and Week 4 (pre-dose). Baseline was defined as the value on Day 1. Percent CFB was calculated as 100 multiplied by the exponential mean change on a log scale minus 1. |
| Secondary | CFB in Ferritin at Week 4 | Baseline (Day 1) and Week 4 | Ferritin was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post dose value at Week 4. |
| Secondary | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | Baseline (Day 1) and Week 4 | TIBC, UIBC and Iron were used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4. |
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 (CFB) in Hemaglobin (Hgb) at Week 4 | Baseline (Day 1) and Week 4 | Intent-to-Treat (ITT) population comprised of all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on treatment assessment. Only those participants with data available at the indicated time points were analyzed. | grams/deciliter (g/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | CFB in Hgb Upto Week 8 | Baseline (Day 1) Upto Week 8 | ITT population. Only those participants available at the specified time points were analyzed. | g/dL | MEAN |
| SECONDARY | Number of Participants Who Achieved Hgb Response at Week 4 | Week 4 | ITT population. Only those participants available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Achieved Hgb Response at Week 4 | Week 4 | ITT population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Reached Pre-defined Hgb Stopping Criteria | Upto Week 4 | ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4 | Baseline (Day 1) Upto Week 4 | ITT population. Only those participants with data available at the indicated time points were analyzed. | International units/liter | MEAN |
| SECONDARY | Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4 | Baseline (Day 1) Upto Week 4 | ITT population. Only those participants with data available at the indicated time points were analyzed. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Percent CFB in Hepcidine Upto Week 4 | Baseline (Day 1) Upto Week 4 | ITT population. Only those participants available at the specified time points were analyzed. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | CFB in Ferritin at Week 4 | Baseline (Day 1) and Week 4 | ITT population. Only those participants with data available at the specified time points were analyzed. | micrograms/liter | MEAN |
| SECONDARY | CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4 | Baseline (Day 1) and Week 4 | ITT population. Only those participants available at the specified time points were analyzed. | micromoles/liter | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group467
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | Placebo | -1.52 | Standard Error 0.212 | grams/deciliter (g/dL) | |
| Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | GSK1278863 4 mg | -0.29 | Standard Error 0.200 | grams/deciliter (g/dL) | |
| Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | GSK1278863 6 mg | -0.02 | Standard Error 0.193 | grams/deciliter (g/dL) | |
| Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | GSK1278863 8 mg | 0.60 | Standard Error 0.202 | grams/deciliter (g/dL) | |
| Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4 | GSK1278863 10 mg | 0.92 | Standard Error 0.196 | grams/deciliter (g/dL) | |
| CFB in Hgb Upto Week 8 | Placebo | CFB at Week 1 | -0.34 | Standard Deviation 0.485 | g/dL |
| CFB in Hgb Upto Week 8 | GSK1278863 4 mg | CFB at Week 1 | -0.23 | Standard Deviation 0.374 | g/dL |
| CFB in Hgb Upto Week 8 | GSK1278863 6 mg | CFB at Week 1 | -0.35 | Standard Deviation 0.462 | g/dL |
| CFB in Hgb Upto Week 8 | GSK1278863 8 mg | CFB at Week 1 | -0.31 | Standard Deviation 0.481 | g/dL |
| CFB in Hgb Upto Week 8 | GSK1278863 10 mg | CFB at Week 1 | -0.17 | Standard Deviation 0.318 | g/dL |
1 to 10 of 467Source ClinicalTrials.gov
See all 467 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 19 | |
| Overall Study | STARTED | GSK1278863 4 mg | 19 | |
| Overall Study | STARTED | GSK1278863 6 mg | 20 | |
| Overall Study | STARTED | GSK1278863 8 mg | 19 | |
| Overall Study | STARTED | GSK1278863 10 mg | 20 | |
| Overall Study | COMPLETED | Placebo | 13 | |
| Overall Study | COMPLETED | GSK1278863 4 mg | 18 | |
| Overall Study | COMPLETED | GSK1278863 6 mg | 20 | |
| Overall Study | COMPLETED | GSK1278863 8 mg | 17 | |
| Overall Study | COMPLETED | GSK1278863 10 mg | 18 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events140
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 | Nasopharyngitis | Infections and infestations | Placebo | 0 | 19 | |
| other | Nasopharyngitis | Infections and infestations | GSK1278863 4 mg | 1 | 19 | |
| other | Nasopharyngitis | Infections and infestations | GSK1278863 6 mg | 0 | 20 | |
| other | Nasopharyngitis | Infections and infestations | GSK1278863 8 mg | 2 | 19 | |
| other | Nasopharyngitis | Infections and infestations | GSK1278863 10 mg | 2 | 20 | |
| other | Pharyngitis | Infections and infestations | Placebo | 0 | 19 | |
| other | Pharyngitis | Infections and infestations | GSK1278863 4 mg | 0 | 19 | |
| other | Pharyngitis | Infections and infestations | GSK1278863 6 mg | 0 | 20 | |
| other | Pharyngitis | Infections and infestations | GSK1278863 8 mg | 0 | 19 | |
| other | Pharyngitis | Infections and infestations | GSK1278863 10 mg | 1 | 20 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 19 |
| Total, all-cause mortality | GSK1278863 4 mg | 0 | 19 |
| Total, all-cause mortality | GSK1278863 6 mg | 0 | 20 |
| Total, all-cause mortality | GSK1278863 8 mg | 0 | 19 |
| Total, all-cause mortality | GSK1278863 10 mg | 0 | 20 |
| Total, other adverse events | Placebo | 4 | 19 |
| Total, other adverse events | GSK1278863 4 mg | 6 | 19 |
| Total, other adverse events | GSK1278863 6 mg | 8 | 20 |
| Total, other adverse events | GSK1278863 8 mg | 7 | 19 |
| Total, other adverse events | GSK1278863 10 mg | 5 | 20 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
For software
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