Trial · NCT03409107
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)
NCT03409107, Phase 3, Completed, GlaxoSmithKline; results first posted 2021-11-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ). Trials, record NCT03409107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03409107
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)
- NCT number
- NCT03409107
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 614 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- Daprodustat (GSK1278863), Placebo, Iron therapy
- First posted
- 2018-01-24
- Last updated
- 2024-04-02
- Other registries' IDs
- eudract:2017-002270-39
- Results first posted
- 2021-11-03
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) | Baseline (Day 1) and Week 24 to Week 28 | Blood samples were collected at given time points from participants for hemoglobin measurements. Evaluation period hemoglobin value was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 24 to Week 28 inclusive). For the primary analysis, the missing post-Baseline hemoglobin values were imputed using pre-specified multiple imputations. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using the Analysis of Covariance (ANCOVA) model with terms for treatment, Baseline hemoglobin, and region. |
| Secondary | Percentage of Participants With Hemoglobin Increase of >=1.0 Grams Per Deciliter From Baseline to Evaluation Period | Baseline (Day 1) and Week 24 to Week 28 | Blood samples were collected at given time points for hemoglobin measurements. Evaluation period hemoglobin value was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 24 to Week 28 inclusive). For the primary analysis, the missing post-Baseline hemoglobin values were imputed using pre-specified multiple imputations. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. Percentage of participants with hemoglobin increase of \>=1.0 grams per deciliter from Baseline to evaluation period was analyzed using Cochran-Mantel-Haenszel (CMH) chi-squared test. The percentage values presented has been rounded off. |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Questionnaire Vitality Domain Score by Traditional Scoring at Week 28 | Baseline (Day 1) and Week 28 | The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the 8 health domains: Physical Functioning, Role-Physical (role limitations caused by physical problems), Social Functioning, Bodily Pain, Mental Health, Role-Emotional (role limitations caused by emotional problems), Vitality, and General Perception of Health.Each domain is scored from 0 (poorer health) to 100 (better health). Vitality domain score ranges from 0-100; higher score indicates a better health state \& better functioning. Change from Baseline was calculated as Post-Dose Visit Value at Week 28 minus Baseline. For primary analysis, the missing on-treatment Week 28 SF-36 Vitality domain scores were imputed using pre-specified multiple imputations. Baseline value was latest non-missing pre-dose assessment on or before randomization date. Analysis was performed using ANCOVA model with terms for treatment, Baseline score, and region. |
| Secondary | Percentage of Participants With Hgb Response (Hgb in the 11-12 Grams/Deciliter Range) During Evaluation Period (Week 24 to Week 28 Inclusive) | Week 24 to Week 28 | Mean hemoglobin during the evaluation period was defined as the mean of all evaluable hemoglobin values during the evaluation period (Week 24 to Week 28 inclusive) including any evaluable unscheduled hemoglobin values that were taken during this period. Percentage of participants with Hgb response was defined as participants with mean Hgb within range (11-12 grams per deciliter during the evaluation period (Week 24 to Week 28 inclusive) and it was analyzed using Cochran-Mantel-Haenszel (CMH) chi-squared test. The percentage values presented has been rounded off. |
| Secondary | Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Hodges-Lehmann Estimate) | Week 24 to Week 28 | Percentage of days for which participant's Hgb was within the target range of 11-12 grams per deciliter during the evaluation period (Week 24 to Week 28 inclusive), including any unscheduled evaluable Hgb values that were taken during this time period. Percentage of time for which Hgb was within the target range (11-12 grams per deciliter) for a participant was calculated by dividing 'the total number of days that Hgb was within range during Week 24 to 28' by 'the total number of days the participant remained on treatment during Week 24 to 28'. |
| Secondary | Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Mann-Whitney Estimate) | Week 24 to Week 28 | Percentage of days for which participant's Hgb was within the target range of 11-12 grams per deciliter during the evaluation period (Week 24 to Week 28 inclusive), including any unscheduled evaluable Hgb values that were taken during this time period. Percentage of time for which Hgb was within the target range (11-12 grams per deciliter) for a participant was calculated by dividing 'the total number of days that Hgb was within range during Week 24 to 28' by 'the total number of days the participant remained on treatment during Week 24 to 28' |
| Secondary | Change From Baseline in Post-randomization Hgb at Week 28 | Baseline (Day 1) and Week 28 | Blood samples were collected at given time points for hemoglobin measurements. Change from Baseline in Hgb was analyzed using a mixed model repeated measures (MMRM) approach. Change from Baseline was calculated as Post-dose visit value minus Baseline. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. |
| Secondary | Rate of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | Up to Week 28 | The incidence rate of participants permanently stopping randomized treatment due to meeting rescue criteria is presented. |
| Secondary | Change From Baseline by Domain and Single Item Scores on the Chronic Kidney Disease -Anemia Questionnaire (CKD-AQ) Symptom Questionnaire | Baseline (Day 1) and Week 28 | CKD-AQ is 21-item patient reported outcomes measure assessing symptoms \& symptom impact in participants with anemia associated with CKD.CKD-AQ identified 3 domains:1.Tired/Low Energy/Weak scale consisting of ten items;2.Chest Pain/Shortness of Breath scale consisting of four items and 3.Cognitive scale consisting of three items;Single items included: 4.Difficulty Sleeping;5.Difficulty Standing for long periods of time;6.Severity-Shortness of breath while sitting/resting;7.Time with Shortness of breath while not doing activity.Single-item measures were recorded based on 0-100 scoring with 0 is worst possible \& 100 is best possible score.Total domain score is calculated as average of items in each domain \& ranged from 0-100 where 0 is worst possible and 100 is best possible score.Change from Baseline was calculated as post-dose visit value minus Baseline.Baseline was latest non-missing pre-dose assessment on or before randomization date. Adjusted mean \& standard error is presented. |
| Secondary | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Baseline (Day 1) and Week 28 | The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated worse outcome. Change from Baseline was calculated as Post-Dose visit value minus Baseline value. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date. Adjusted mean and standard error is presented. |
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 | Mean Change in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) | Baseline (Day 1) and Week 24 to Week 28 | Intent-to-Treat (ITT) Population comprised all randomized participants regardless of whether they took study drug. | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hemoglobin Increase of >=1.0 Grams Per Deciliter From Baseline to Evaluation Period | Baseline (Day 1) and Week 24 to Week 28 | Intent-to-Treat population. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Short Form-36 (SF-36) Questionnaire Vitality Domain Score by Traditional Scoring at Week 28 | Baseline (Day 1) and Week 28 | Intent-to-Treat Population. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hgb Response (Hgb in the 11-12 Grams/Deciliter Range) During Evaluation Period (Week 24 to Week 28 Inclusive) | Week 24 to Week 28 | Intent-to-Treat Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Hodges-Lehmann Estimate) | Week 24 to Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Percentage of days | MEDIAN |
| SECONDARY | Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Mann-Whitney Estimate) | Week 24 to Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Percentage of days | MEDIAN |
| SECONDARY | Change From Baseline in Post-randomization Hgb at Week 28 | Baseline (Day 1) and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | Up to Week 28 | Intent-to-Treat Population. | Events per 100 person year | NUMBER |
| SECONDARY | Change From Baseline by Domain and Single Item Scores on the Chronic Kidney Disease -Anemia Questionnaire (CKD-AQ) Symptom Questionnaire | Baseline (Day 1) and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient Global Impression of Severity (PGI-S) | Baseline (Day 1) and Week 28 | Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) | Placebo | 0.19 | Standard Error 0.062 | Grams per deciliter | |
| Mean Change in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) | Daprodustat | 1.58 | Standard Error 0.061 | Grams per deciliter | |
| Percentage of Participants With Hemoglobin Increase of >=1.0 Grams Per Deciliter From Baseline to Evaluation Period | Placebo | 18 | Percentage of participants | ||
| Percentage of Participants With Hemoglobin Increase of >=1.0 Grams Per Deciliter From Baseline to Evaluation Period | Daprodustat | 77 | Percentage of participants | ||
| Change From Baseline in Short Form-36 (SF-36) Questionnaire Vitality Domain Score by Traditional Scoring at Week 28 | Placebo | 1.93 | Standard Error 1.161 | Scores on a scale | |
| Change From Baseline in Short Form-36 (SF-36) Questionnaire Vitality Domain Score by Traditional Scoring at Week 28 | Daprodustat | 7.29 | Standard Error 1.121 | Scores on a scale | |
| Percentage of Participants With Hgb Response (Hgb in the 11-12 Grams/Deciliter Range) During Evaluation Period (Week 24 to Week 28 Inclusive) | Placebo | 8 | Percentage of participants | ||
| Percentage of Participants With Hgb Response (Hgb in the 11-12 Grams/Deciliter Range) During Evaluation Period (Week 24 to Week 28 Inclusive) | Daprodustat | 52 | Percentage of participants | ||
| Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Hodges-Lehmann Estimate) | Placebo | 0.00 | Full Range 0.0 to 100.0 | Percentage of days | |
| Percentage of Time With Hgb Within the Target Range (11-12 Grams Per Deciliter) During Evaluation Period (Week 24 to Week 28 Inclusive) (Hodges-Lehmann Estimate) | Daprodustat | 53.59 | Full Range 0.0 to 100.0 | Percentage of days |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 307 | |
| Overall Study | STARTED | Daprodustat | 307 | |
| Overall Study | COMPLETED | Placebo | 290 | |
| Overall Study | COMPLETED | Daprodustat | 300 | |
| Overall Study | NOT COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | Daprodustat | 7 |
Source ClinicalTrials.gov
Adverse events246
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 | Diarrhoea | Gastrointestinal disorders | Placebo | 17 | 306 | 22 |
| other | Diarrhoea | Gastrointestinal disorders | Daprodustat | 24 | 308 | 26 |
| other | Hypertension | Vascular disorders | Placebo | 14 | 306 | 14 |
| other | Hypertension | Vascular disorders | Daprodustat | 21 | 308 | 27 |
| other | Oedema peripheral | General disorders | Placebo | 21 | 306 | 23 |
| other | Oedema peripheral | General disorders | Daprodustat | 12 | 308 | 14 |
| serious | Acute kidney injury | Renal and urinary disorders | Placebo | 5 | 306 | 5 |
| serious | Acute kidney injury | Renal and urinary disorders | Daprodustat | 5 | 308 | 6 |
| serious | Renal failure | Renal and urinary disorders | Placebo | 6 | 306 | 6 |
| serious | Renal failure | Renal and urinary disorders | Daprodustat | 2 | 308 | 2 |
1 to 10 of 246Source ClinicalTrials.gov
See all 246 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 16 | 306 |
| Total, all-cause mortality | Daprodustat | 10 | 308 |
| Total, other adverse events | Placebo | 44 | 306 |
| Total, other adverse events | Daprodustat | 49 | 308 |
| Total, serious adverse events | Placebo | 68 | 306 |
| Total, serious adverse events | Daprodustat | 62 | 308 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Daprodustat vs Placebo: deaths from any cause | Trial comparisons |
| Daprodustat vs Placebo: 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.
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Read this trial from software.
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