Trial · NCT02791763
Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia
NCT02791763, Phase 3, Completed, GlaxoSmithKline; results first posted 2019-11-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia. Trials, record NCT02791763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02791763
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia
- NCT number
- NCT02791763
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 355 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- 1 to 4 mg tablets of GSK1278863, 6 mg GSK1278863 tablet, Epoetin beta pegol
- First posted
- 2016-06-07
- Last updated
- 2021-05-18
- Results first posted
- 2019-11-13
- Limitations and caveats
- A participant in ND daprodustat/ND epoetin beta pegol/PD daprodustat had data entry error with dose level. This had an impact on outcomes of dose level and number of dose adjustment.
Source ClinicalTrials.gov
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | Weeks 40 to 52 | The mean hemoglobin during the primary efficacy evaluation period in ND participants was estimated by a statistical model using Mixed Model Repeated Measures (MMRM). |
| Secondary | Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period were summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period. |
| Secondary | Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | The percentage of ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period. |
| Secondary | Change From Baseline in Hgb at Week 4 in ND Participants | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at Week 4 in ND participants is presented. |
| Secondary | Change From Baseline in Hgb at Week 4 in PD Participants | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at week 4 in PD participants is presented. |
| Secondary | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
| Secondary | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
| Secondary | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
| Secondary | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4. |
| Secondary | Daprodustat Dose Level by Visit in ND Participants | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48 | Daprodustat dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75). |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 registered outcomesOutcomes66
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | Weeks 40 to 52 | Intent to treat (ITT) Population comprised of cohort 1 participants (only erythropoiesis stimulating agent \[ESA\] users) and cohort 3 participants (both ESA users and ESA non-users) who were given randomization number with Hgb measurement at both Baseline and at least one scheduled visits following the Baseline. | Grams per deciliter (g/dL) | MEAN |
| SECONDARY | Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | Modified intent to treat (mITT) comprised of all ITT participants who had at least one Hgb measurement during the efficacy evaluation period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | mITT Population | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hgb at Week 4 in ND Participants | Baseline (Day 1) and Week 4 | ITT Population. Only those participants with data available at the specified data points were analyzed. | g/dL | MEAN |
| SECONDARY | Change From Baseline in Hgb at Week 4 in PD Participants | Baseline (Day 1) and Week 4 | Efficacy peritoneal dialysis (PD) Population comprised of PD participants who were given randomization number with Hgb measurement at both Baseline and at least one scheduled visits following the Baseline. | g/dL | MEAN |
| SECONDARY | Number of ND Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | ITT Population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of ND Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | ITT Population. Only those participants with data available at the specified data points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Number of PD Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Efficacy PD Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of PD Participants by Hgb Change From Baseline Category at Week 4 | Baseline (Day 1) and Week 4 | Efficacy PD Population | Percentage of Participants | NUMBER |
| SECONDARY | Daprodustat Dose Level by Visit in ND Participants | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48 | ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Milligrams per day (mg/day) | MEDIAN |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 outcomesResults by group407
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | Daprodustat in ND Participants | 11.97 | Standard Error 0.061 | Grams per deciliter (g/dL) | |
| Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants | Epoetin Beta Pegol in ND Participants | 11.86 | Standard Error 0.063 | Grams per deciliter (g/dL) | |
| Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Daprodustat in ND Participants | Responder | 81 | Participants | |
| Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Epoetin Beta Pegol in ND Participants | Responder | 80 | Participants | |
| Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Daprodustat in ND Participants | Non-Responder | 7 | Participants | |
| Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Epoetin Beta Pegol in ND Participants | Non-Responder | 7 | Participants | |
| Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Daprodustat in ND Participants | Responder | 92 | Percentage of participants | |
| Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Epoetin Beta Pegol in ND Participants | Responder | 92 | Percentage of participants | |
| Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Daprodustat in ND Participants | Non-Responder | 8 | Percentage of participants | |
| Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Epoetin Beta Pegol in ND Participants | Non-Responder | 8 | Percentage of participants |
1 to 10 of 407Source ClinicalTrials.gov
See all 407 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daprodustat in ND Participants | 149 | |
| Overall Study | STARTED | Epoetin Beta Pegol in ND Participants | 150 | |
| Overall Study | STARTED | Daprodustat in PD Participants | 56 | |
| Overall Study | COMPLETED | Daprodustat in ND Participants | 111 | |
| Overall Study | COMPLETED | Epoetin Beta Pegol in ND Participants | 113 | |
| Overall Study | COMPLETED | Daprodustat in PD Participants | 43 | |
| Overall Study | NOT COMPLETED | Daprodustat in ND Participants | 38 | |
| Overall Study | NOT COMPLETED | Epoetin Beta Pegol in ND Participants | 37 | |
| Overall Study | NOT COMPLETED | Daprodustat in PD Participants | 13 |
Source ClinicalTrials.gov
Adverse events243
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 | Daprodustat in ND Participants | 49 | 149 | 68 |
| other | Nasopharyngitis | Infections and infestations | Epoetin Beta Pegol in ND Participants | 56 | 150 | 77 |
| other | Nasopharyngitis | Infections and infestations | Daprodustat in PD Participants | 16 | 56 | 23 |
| other | Influenza | Infections and infestations | Daprodustat in ND Participants | 8 | 149 | 8 |
| other | Influenza | Infections and infestations | Epoetin Beta Pegol in ND Participants | 8 | 150 | 9 |
| other | Influenza | Infections and infestations | Daprodustat in PD Participants | 0 | 56 | 0 |
| other | Catheter site infection | Infections and infestations | Daprodustat in ND Participants | 0 | 149 | 0 |
| other | Catheter site infection | Infections and infestations | Epoetin Beta Pegol in ND Participants | 0 | 150 | 0 |
| other | Catheter site infection | Infections and infestations | Daprodustat in PD Participants | 9 | 56 | 15 |
| other | Device related infection | Infections and infestations | Daprodustat in ND Participants | 0 | 149 | 0 |
1 to 10 of 243Source ClinicalTrials.gov
See all 243 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daprodustat in ND Participants | 1 | 149 |
| Total, all-cause mortality | Epoetin Beta Pegol in ND Participants | 2 | 150 |
| Total, all-cause mortality | Daprodustat in PD Participants | 0 | 56 |
| Total, other adverse events | Daprodustat in ND Participants | 85 | 149 |
| Total, other adverse events | Epoetin Beta Pegol in ND Participants | 91 | 150 |
| Total, other adverse events | Daprodustat in PD Participants | 41 | 56 |
| Total, serious adverse events | Daprodustat in ND Participants | 34 | 149 |
| Total, serious adverse events | Epoetin Beta Pegol in ND Participants | 43 | 150 |
| Total, serious adverse events | Daprodustat in PD Participants | 26 | 56 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Daprodustat in ND Participants vs Epoetin Beta Pegol in ND Participants: Number of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | Trial comparisons |
| Daprodustat in ND Participants vs Epoetin Beta Pegol in ND Participants: Number of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL | Trial comparisons |
| Daprodustat in ND Participants vs Epoetin Beta Pegol in ND Participants: Number of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL | Trial comparisons |
| Daprodustat in ND Participants vs Epoetin Beta Pegol in ND Participants: Number of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period | Trial comparisons |
| Daprodustat in ND Participants vs Epoetin Beta Pegol in ND Participants: Number of ND Participants Who Used Oral Iron During the Treatment Period | Trial comparisons |
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02791763
GET https://conductscience.org/api/trials/v1/NCT02791763/registered?page=2