Trial · NCT03400033
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)
NCT03400033, Phase 3, Completed, GlaxoSmithKline; results first posted 2021-07-12
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-Three-times Weekly Dosing in Dialysis (ASCEND-TD). Trials, record NCT03400033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03400033
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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-Three-times Weekly Dosing in Dialysis (ASCEND-TD)
- NCT number
- NCT03400033
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 407 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- Daprodustat tablets, Matching placebo tablets, Epoetin alfa vials, Saline vials or bags
- First posted
- 2018-01-17
- Last updated
- 2021-07-12
- Other registries' IDs
- eudract:2017-004372-56
- Results first posted
- 2021-07-12
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Hemoglobin Levels Over the 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 hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). 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, including those from unscheduled visits. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Analysis was performed using the Analysis of Covariance (ANCOVA) model with terms for treatment, Baseline hemoglobin, and region. |
| Secondary | Mean Average Monthly On-treatment Intravenous (IV) Iron Dose Per Participant | Day 1 to Week 52 | Average monthly IV iron dose (mg) per participant during Day 1 to Week 52 was determined by calculating the total IV iron dose per participant from Day 1 to Week 52 while the participant was on study treatment and dividing by (the number of days the participant was on study treatment divided by 30.4375 days). Analysis was performed using the ANCOVA model with terms for treatment, Baseline monthly IV iron dose, and region. |
| Secondary | Change From Baseline in Hemoglobin Levels at Week 52 | Baseline (Pre-dose on Day 1) and Week 52 | Blood samples were collected from participants for hemoglobin measurements. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the post-randomization visit value minus Baseline value. Analysis was performed using a mixed model repeated measures (MMRM) model fitted to hemoglobin data collected after Baseline up to Week 52, excluding values collected during the stabilization period (Day 1 to Week 28). The model included factors for treatment, time, region, Baseline hemoglobin and Baseline hemoglobin by time and treatment by time interaction terms. |
| Secondary | Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | Week 28 to Week 52 | Participants received treatment during the study to achieve or maintain hemoglobin level in the target range. Percentage of time for which hemoglobin level was maintained within the analysis range (10 to 11.5 grams/deciliter) has been presented. |
| Secondary | Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | Week 28 to Week 52 | Mean hemoglobin during the evaluation period was defined as the mean of all evaluable hemoglobin values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled hemoglobin values that were taken during this time period. Hemoglobin responders were defined as the number of participants with a mean hemoglobin during the evaluation period that falls within the hemoglobin analysis range of 10-11.5 grams/deciliter. |
| Secondary | Percentage of Participants Permanently Stopping Study Treatment Due to Meeting Rescue Criteria | Up to Week 52 | Percentage of participants permanently stopping study treatment due to meeting rescue criteria has been presented. |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) at Week 52 | Baseline (Week -4 ) and Week 52 | Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the on-treatment visit value minus Baseline value. Analysis was performed using MMRM model with treatment group, time, region, Baseline value, Baseline value\*time, treatment group\*time as variables. |
| Secondary | Change From Baseline in SBP, DBP and MAP at End of Treatment | Baseline (Week -4) and end of treatment (last on-treatment value until Week 52) | Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the last on-treatment visit value minus Baseline value. Analysis was performed using ANCOVA model with terms for treatment group, region and Baseline value. Adjusted mean and standard error have been presented. |
| Secondary | Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years | Up to 52 weeks | BP exacerbation event is defined (based on post-dialysis BP) as SBP \>=25 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 BP Exacerbation Event During the Study | Up to 52 weeks | BP exacerbation (based on post-dialysis BP) is defined as: SBP \>= 25 mmHg increased from Baseline or SBP \>=180mmHg; or DBP \>=15 mmHg increase from Baseline or DBP \>=110 mmHg. Number of participants with at least 1 BP exacerbation event have been reported. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 Levels Over the Evaluation Period (Week 28 to Week 52) | Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) | All Randomized (Intent-to-treat \[ITT\]) Population comprised of all randomized participants. Any participant who received a treatment randomization number was considered to have been randomized. | Grams per deciliter (g/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Average Monthly On-treatment Intravenous (IV) Iron Dose Per Participant | Day 1 to Week 52 | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Milligrams | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hemoglobin Levels at Week 52 | Baseline (Pre-dose on Day 1) and Week 52 | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | Week 28 to Week 52 | All Randomized (ITT) Population. Only those participants with at least one evaluable hemoglobin value during the evaluation period were analyzed. | Percentage of days | MEDIAN |
| SECONDARY | Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | Week 28 to Week 52 | All Randomized (ITT) Population. Only those participants with at least one evaluable hemoglobin value during the evaluation period were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Permanently Stopping Study Treatment Due to Meeting Rescue Criteria | Up to Week 52 | All Randomized (ITT) Population | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) at Week 52 | Baseline (Week -4 ) and Week 52 | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Millimeter of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SBP, DBP and MAP at End of Treatment | Baseline (Week -4) and end of treatment (last on-treatment value until Week 52) | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years | Up to 52 weeks | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Events per 100 participant years | NUMBER |
| SECONDARY | Number of Participants With at Least One BP Exacerbation Event During the Study | Up to 52 weeks | All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group162
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 Levels Over the Evaluation Period (Week 28 to Week 52) | Daprodustat | -0.04 | Standard Error 0.045 | Grams per deciliter (g/dL) | |
| Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52) | Epoetin Alfa | 0.02 | Standard Error 0.066 | Grams per deciliter (g/dL) | |
| Mean Average Monthly On-treatment Intravenous (IV) Iron Dose Per Participant | Daprodustat | 98.11 | Standard Error 11.049 | Milligrams | |
| Mean Average Monthly On-treatment Intravenous (IV) Iron Dose Per Participant | Epoetin Alfa | 106.23 | Standard Error 15.569 | Milligrams | |
| Change From Baseline in Hemoglobin Levels at Week 52 | Daprodustat | -0.03 | Standard Error 0.069 | Grams per deciliter | |
| Change From Baseline in Hemoglobin Levels at Week 52 | Epoetin Alfa | 0.11 | Standard Error 0.098 | Grams per deciliter | |
| Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | Daprodustat | 70.83 | Inter-Quartile Range 50.98 to 91.07 | Percentage of days | |
| Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | Epoetin Alfa | 61.76 | Inter-Quartile Range 29.69 to 85.19 | Percentage of days | |
| Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | Daprodustat | 172 | Participants | ||
| Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | Epoetin Alfa | 68 | Participants |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 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 | 270 | |
| Overall Study | STARTED | Epoetin Alfa | 137 | |
| Overall Study | COMPLETED | Daprodustat | 269 | |
| Overall Study | COMPLETED | Epoetin Alfa | 135 | |
| Overall Study | NOT COMPLETED | Daprodustat | 1 | |
| Overall Study | NOT COMPLETED | Epoetin Alfa | 2 |
Source ClinicalTrials.gov
Adverse events354
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 | Daprodustat | 23 | 270 | 36 |
| other | Diarrhoea | Gastrointestinal disorders | Epoetin Alfa | 14 | 136 | 19 |
| other | Vomiting | Gastrointestinal disorders | Daprodustat | 15 | 270 | 16 |
| other | Vomiting | Gastrointestinal disorders | Epoetin Alfa | 13 | 136 | 15 |
| other | Nausea | Gastrointestinal disorders | Daprodustat | 6 | 270 | 8 |
| other | Nausea | Gastrointestinal disorders | Epoetin Alfa | 11 | 136 | 21 |
| other | Abdominal pain | Gastrointestinal disorders | Daprodustat | 7 | 270 | 8 |
| other | Abdominal pain | Gastrointestinal disorders | Epoetin Alfa | 9 | 136 | 9 |
| other | Hypertension | Vascular disorders | Daprodustat | 22 | 270 | 35 |
| other | Hypertension | Vascular disorders | Epoetin Alfa | 14 | 136 | 19 |
1 to 10 of 354Source ClinicalTrials.gov
See all 354 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daprodustat | 18 | 270 |
| Total, all-cause mortality | Epoetin Alfa | 10 | 136 |
| Total, other adverse events | Daprodustat | 74 | 270 |
| Total, other adverse events | Epoetin Alfa | 42 | 136 |
| Total, serious adverse events | Daprodustat | 80 | 270 |
| Total, serious adverse events | Epoetin Alfa | 47 | 136 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Daprodustat vs Epoetin Alfa: Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52) | Trial comparisons |
| Daprodustat vs Epoetin Alfa: Number of Participants With at Least One BP Exacerbation Event During the Study | Trial comparisons |
| Daprodustat vs Epoetin Alfa: deaths from any cause | Trial comparisons |
| Daprodustat vs Epoetin 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/NCT03400033
GET https://conductscience.org/api/trials/v1/NCT03400033/results?page=2