Trial · NCT02969655
A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)
NCT02969655, Phase 3, Completed, GlaxoSmithKline; results first posted 2019-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD). Trials, record NCT02969655. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02969655
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)
- NCT number
- NCT02969655
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 271 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- Daprodustat small, Daprodustat small placebo, Daprodustat large, Daprodustat large placebo, Darbepoetin alfa, Darbepoetin alfa placebo
- First posted
- 2016-11-21
- Last updated
- 2020-11-27
- Results first posted
- 2019-11-29
Source ClinicalTrials.gov
Registered outcomes18
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) | Weeks 40 to 52 | The mean hemoglobin during the Evaluation Period was estimated by a statistical model. |
| Secondary | Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | The percentage of participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Odds ratio was estimated using a logistic regression and provided along with its 95% CI and a one-sided p-value. |
| Secondary | Change From Baseline in Hgb (Hgb Increase Rate) at Week 4 | Baseline and Week 4 | Change from Baseline was calculated as the post-dose Week 4 visit value minus the Baseline value. |
| Secondary | Percentage of Participants by Hgb Change From Baseline Category at Week 4 | Week 4 | Percentage of participants within each category were provided only for daprodustat and the categories were classified into 6 (i.e., \<=-2, \>-2 to -1, \>-1 to 0, \>0 to 1, \>1 to 2, \>2 grams per deciliter \[g/dL\]). In addition, 'within 1.0 g/dL (i.e., \<=-1 and \>=1) and over 2.0 g/dL (i.e., \<-2 and \>2) categories were provided. |
| Secondary | Distribution of Daprodustat Dose Level by Visit | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44, and 48) | Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Daprodustat. Median along with the interquartile range (25th and 75th percentile) has been presented. |
| Secondary | Distribution of Darbepoetin Alfa Dose Level by Visit | Day 1, Weeks 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48, and 50 | Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Darbepoetin Alfa. Median along with the interquartile range (25th and 75th percentile) has been presented. |
| Secondary | Duration of Treatment Interruption Due to Hgb >13 g/dL | Up to Week 52 | Duration of treatment interruption due to Hgb \>13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for the daprodustat group. |
| Secondary | Number of Dose Adjustments for Daprodustat | Up to Week 52 | Number of dose adjustments has been presented only for daprodustat. |
| Secondary | Hgb Values at Each Assessment Visit | Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented. |
| Secondary | Change From Baseline in Hgb Values at Each Assessment Visit | Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calcuated as the post-dose visit value minus the Baseline value. Change from Baseline Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented. |
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 | Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Weeks 40 to 52 | Intent to treat (ITT) Population comprised of all randomized participants who had a Baseline and at least one post Baseline schedule Hgb assessment. | Grams per deciliter (g/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 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 evaluation period. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hgb (Hgb Increase Rate) at Week 4 | Baseline and Week 4 | ITT Population | g/dL | MEAN |
| SECONDARY | Percentage of Participants by Hgb Change From Baseline Category at Week 4 | Week 4 | ITT Population. Data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency. | Percentage of participants | NUMBER |
| SECONDARY | Distribution of Daprodustat Dose Level by Visit | Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44, and 48) | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). | milligrams per day (mg/day) | MEDIAN |
| SECONDARY | Distribution of Darbepoetin Alfa Dose Level by Visit | Day 1, Weeks 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48, and 50 | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). | micrograms per week (ug/week) | MEDIAN |
| SECONDARY | Duration of Treatment Interruption Due to Hgb >13 g/dL | Up to Week 52 | ITT Population. Only those participants with data available at the time of assessment were used for analysis. Summary data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency. Median along with inter quartile range (25th and 75th percentile) have been presented. | Days | MEDIAN |
| SECONDARY | Number of Dose Adjustments for Daprodustat | Up to Week 52 | ITT Population. Summary data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency. | Dose adjustments | MEDIAN |
| SECONDARY | Hgb Values at Each Assessment Visit | Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). | g/dL | MEAN |
| SECONDARY | Change From Baseline in Hgb Values at Each Assessment Visit | Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52 | ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). | g/dL | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group163
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) | Daprodustat | 10.89 | Standard Error 0.062 | Grams per deciliter (g/dL) | |
| Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Darbepoetin Alfa | 10.83 | Standard Error 0.060 | Grams per deciliter (g/dL) | |
| Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Daprodustat | Responder | 88 | Percentage of participants | |
| Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Darbepoetin Alfa | Responder | 90 | Percentage of participants | |
| Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Daprodustat | Non-responder | 13 | Percentage of participants | |
| Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) | Darbepoetin Alfa | Non-responder | 10 | Percentage of participants | |
| Change From Baseline in Hgb (Hgb Increase Rate) at Week 4 | Daprodustat | -0.42 | Standard Deviation 0.898 | g/dL | |
| Change From Baseline in Hgb (Hgb Increase Rate) at Week 4 | Darbepoetin Alfa | 0.08 | Standard Deviation 0.525 | g/dL | |
| Percentage of Participants by Hgb Change From Baseline Category at Week 4 | Daprodustat | <= -2.0 | 5 | Percentage of participants | |
| Percentage of Participants by Hgb Change From Baseline Category at Week 4 | Daprodustat | > -2.0 and <= -1.0 | 21 | Percentage of participants |
1 to 10 of 163Source ClinicalTrials.gov
See all 163 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daprodustat | 136 | |
| Overall Study | STARTED | Darbepoetin Alfa | 135 | |
| Overall Study | COMPLETED | Daprodustat | 115 | |
| Overall Study | COMPLETED | Darbepoetin Alfa | 120 | |
| Overall Study | NOT COMPLETED | Daprodustat | 21 | |
| Overall Study | NOT COMPLETED | Darbepoetin Alfa | 15 |
Source ClinicalTrials.gov
Adverse events148
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 | 57 | 136 | 110 |
| other | Nasopharyngitis | Infections and infestations | Darbepoetin Alfa | 73 | 135 | 135 |
| other | Pharyngitis | Infections and infestations | Daprodustat | 10 | 136 | 11 |
| other | Pharyngitis | Infections and infestations | Darbepoetin Alfa | 6 | 135 | 6 |
| other | Gastroenteritis | Infections and infestations | Daprodustat | 7 | 136 | 7 |
| other | Gastroenteritis | Infections and infestations | Darbepoetin Alfa | 2 | 135 | 2 |
| other | Shunt stenosis | Injury, poisoning and procedural complications | Daprodustat | 16 | 136 | 30 |
| other | Shunt stenosis | Injury, poisoning and procedural complications | Darbepoetin Alfa | 15 | 135 | 28 |
| other | Contusion | Injury, poisoning and procedural complications | Daprodustat | 17 | 136 | 21 |
| other | Contusion | Injury, poisoning and procedural complications | Darbepoetin Alfa | 10 | 135 | 12 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daprodustat | 0 | 136 |
| Total, all-cause mortality | Darbepoetin Alfa | 1 | 135 |
| Total, other adverse events | Daprodustat | 102 | 136 |
| Total, other adverse events | Darbepoetin Alfa | 102 | 135 |
| Total, serious adverse events | Daprodustat | 21 | 136 |
| Total, serious adverse events | Darbepoetin Alfa | 37 | 135 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Daprodustat vs Darbepoetin Alfa: Number of Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks | Trial comparisons |
| Daprodustat vs Darbepoetin Alfa: deaths from any cause | Trial comparisons |
| Daprodustat vs Darbepoetin Alfa: serious adverse events | 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/NCT02969655
GET https://conductscience.org/api/trials/v1/NCT02969655/results?page=2