Trial · NCT03029208
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)
NCT03029208, Phase 3, Completed, GlaxoSmithKline; results first posted 2021-10-20
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 Incident Dialysis (ASCEND-ID). Trials, record NCT03029208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03029208
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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 Incident Dialysis (ASCEND-ID)
- NCT number
- NCT03029208
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 312 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- Daprodustat, Darbepoetin alfa, Iron therapy
- First posted
- 2017-01-24
- Last updated
- 2021-10-20
- Other registries' IDs
- eudract:2016-000507-86
- Results first posted
- 2021-10-20
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) | Blood samples were collected from participants for Hgb measurement. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb 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 was defined as the latest non-missing pre-dose assessment on or before the randomization date. An analysis of covariance (ANCOVA) model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95 percent (%) confidence interval (CI) for the treatment difference (daprodustat-darbepoetin alfa). |
| Secondary | Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52 | Baseline (Day 1) to Week 52 | Total IV iron dose per participant was calculated from Day 1 to the earliest of (Week 52 visit date, first blood \[red blood cells or whole blood\] transfusion date and treatment stop date plus \[+\] 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. Average monthly IV iron dose was calculated by Total IV iron dose divided by (/) (the number of days from Day 1 to the earliest of \[Week 52 visit date, first blood transfusion date and treatment stop date +1\] /30.4375 days). Data for participants until they underwent a red blood cells or whole blood transfusion was included in the analysis. |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | Baseline (Day 1) and Week 52 | SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using mixed model repeated measures (MMRM) model. |
| Secondary | Change From Baseline in SBP, DBP, MAP at End of Treatment | Baseline (Day 1) and end of treatment (last on-treatment value until Week 52) | SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. End of treatment value for the blood pressure parameters were defined as the latest value on or before the last non-zero dose date plus (+) 1 day. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using ANCOVA model. |
| Secondary | Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years | Up to Week 52 | BP exacerbation event is defined (based on post-dialysis BP) as SBP \>=25 millimeter of mercury (mmHg) increased from Baseline or SBP \>=180 mmHg; or DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model. |
| Secondary | Number of Participants With at Least One Blood Pressure Exacerbation Event During Study | Up to Week 52 | BP exacerbation was defined (based on post-dialysis BP) as: SBP \>=25 mmHg increased from Baseline or SBP \>=180 mmHg; DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. Number of participants with at least one blood pressure exacerbation event is presented. |
| Secondary | Change From Baseline in Post-randomization Hgb at Week 52 | Baseline (Day 1) and Week 52 | Blood samples were collected from participants for Hgb measurements. Change from Baseline was calculated as post-dose visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. |
| Secondary | Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52) | Weeks 28 to 52 | Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as number of participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL. |
| Secondary | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis | Weeks 28 to 52 | Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'. |
| Secondary | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis | Weeks 28 to 52 | Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time for which Hgb was within range for a participant was calculated by dividing 'the total number of days that Hgb was within range during Weeks 28 to 52' by 'the total number of days the participant remained on treatment during Weeks 28 to 52'. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) | Intent-to-Treat (ITT) Population comprised all randomized participants (who received a treatment randomization number). | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52 | Baseline (Day 1) to Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Milligram | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | Baseline (Day 1) and Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Millimeter of mercury | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SBP, DBP, MAP at End of Treatment | Baseline (Day 1) and end of treatment (last on-treatment value until Week 52) | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Millimeter of mercury | LEAST_SQUARES_MEAN |
| SECONDARY | Blood Pressure (BP) Exacerbation Events Rate Per 100 Participant Years | Up to Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Events per 100 participant year | NUMBER |
| SECONDARY | Number of Participants With at Least One Blood Pressure Exacerbation Event During Study | Up to Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Post-randomization Hgb at Week 52 | Baseline (Day 1) and Week 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52) | Weeks 28 to 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis | Weeks 28 to 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Percentage of days | MEDIAN |
| SECONDARY | Percentage of Time for Which Hgb Was Within the Analysis Range (10 to 11.5 g/dL) During Evaluation Period (Week 28 to Week 52): Superiority Analysis | Weeks 28 to 52 | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Percentage of days | MEDIAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group295
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) | Daprodustat | 1.02 | Standard Error 0.086 | Grams per deciliter | |
| Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) | Darbepoetin Alfa | 1.12 | Standard Error 0.085 | Grams per deciliter | |
| Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52 | Daprodustat | 144.7 | Standard Error 10.90 | Milligram | |
| Average Monthly Intravenous Iron Dose (Milligrams) From Baseline to Week 52 | Darbepoetin Alfa | 125.3 | Standard Error 10.97 | Milligram | |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | Daprodustat | SBP | -3.57 | Standard Error 2.063 | Millimeter of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | Darbepoetin Alfa | SBP | -6.80 | Standard Error 2.931 | Millimeter of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | Daprodustat | DBP | 0.21 | Standard Error 1.216 | Millimeter of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | Darbepoetin Alfa | DBP | -4.01 | Standard Error 1.650 | Millimeter of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | Daprodustat | MAP | -0.95 | Standard Error 1.364 | Millimeter of mercury |
| Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) at Week 52 | Darbepoetin Alfa | MAP | -5.05 | Standard Error 1.894 | Millimeter of mercury |
1 to 10 of 295Source ClinicalTrials.gov
See all 295 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 | 157 | |
| Overall Study | STARTED | Darbepoetin Alfa | 155 | |
| Overall Study | COMPLETED | Daprodustat | 155 | |
| Overall Study | COMPLETED | Darbepoetin Alfa | 151 | |
| Overall Study | NOT COMPLETED | Daprodustat | 2 | |
| Overall Study | NOT COMPLETED | Darbepoetin Alfa | 4 |
Source ClinicalTrials.gov
Adverse events284
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 | Hypertension | Vascular disorders | Daprodustat | 27 | 157 | 51 |
| other | Hypertension | Vascular disorders | Darbepoetin Alfa | 24 | 155 | 35 |
| other | Dialysis hypotension | Vascular disorders | Daprodustat | 21 | 157 | 34 |
| other | Dialysis hypotension | Vascular disorders | Darbepoetin Alfa | 15 | 155 | 22 |
| other | Hypotension | Vascular disorders | Daprodustat | 7 | 157 | 8 |
| other | Hypotension | Vascular disorders | Darbepoetin Alfa | 9 | 155 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | Daprodustat | 14 | 157 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | Darbepoetin Alfa | 10 | 155 | 10 |
| other | Vomiting | Gastrointestinal disorders | Daprodustat | 11 | 157 | 16 |
| other | Vomiting | Gastrointestinal disorders | Darbepoetin Alfa | 5 | 155 | 5 |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daprodustat | 17 | 157 |
| Total, all-cause mortality | Darbepoetin Alfa | 12 | 155 |
| Total, other adverse events | Daprodustat | 76 | 157 |
| Total, other adverse events | Darbepoetin Alfa | 74 | 155 |
| Total, serious adverse events | Daprodustat | 52 | 157 |
| Total, serious adverse events | Darbepoetin Alfa | 51 | 155 |
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 vs Darbepoetin Alfa: Number of Participants With at Least One Blood Pressure Exacerbation Event During Study | Trial comparisons |
| Daprodustat vs Darbepoetin Alfa: Number of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria | Trial comparisons |
| Daprodustat vs Darbepoetin Alfa: Number of Hgb Responders (Hgb in the Analysis Range of 10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52) | 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/NCT03029208
GET https://conductscience.org/api/trials/v1/NCT03029208/registered?page=2