Trial · NCT03029247
Anemia Study in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Blood Pressure (ASCEND-BP)
NCT03029247, Phase 2, Completed, GlaxoSmithKline; results first posted 2021-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anemia Study in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Blood Pressure (ASCEND-BP). Trials, record NCT03029247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03029247
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anemia Study in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Blood Pressure (ASCEND-BP)
- NCT number
- NCT03029247
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 105 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- Daprodustat, Epoetin alfa
- First posted
- 2017-01-24
- Last updated
- 2021-06-03
- Results first posted
- 2021-06-03
Source ClinicalTrials.gov
Registered outcomes57
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57 | Up to 6 hours post dose on Day 57 | The effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM after 8 weeks of Hgb maintenace therapy on Day 57. Analysis was based on "analysis of covariance (ANCOVA) with terms for treatment, prior erythropoiesis-stimulating agent (ESA) dose (low/high), post-Hemodialysis dependent (HD)/pre-AC 1 SBP, difference between post-HD/pre-AC 2 SBP and post-HD/pre-AC 1 SBP and treatment by difference in post-HD SBP between AC 1 and 2 interaction." Least square (LS) mean of 6 hour average SBP post AC2 on Day 57 and its corresponding standard error has been presented. |
| Secondary | Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | Up to 6 hours post dose on Day 1 | The initial effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM over 6 hour post-dosing on Day 1. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 SBP, DBP and MAP. LS mean of 6 hour average SBP, DBP and MAP post AC1 on Day 1 and its corresponding standard error has been presented. |
| Secondary | Average of Heart Rate (HR) Measured by ABPM Over 6 Hour Post Dosing on Day 1 | Up to 6 hours post dose on Day 1 | The initial effect of daprodustat and epoetin alfa on HR was compared using ABPM over 6 hour post-dosing on Day 1. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 HR. LS mean of 6 hour average HR post AC1 on Day 1 and its corresponding standard error has been presented. |
| Secondary | Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1 | Up to 24 hours post dose on Day 1 | The initial effect of daprodustat and epoetin alfa on blood pressure was compared using AUEC of SBP, DBP and MAP measured by ABPM over 24-hour post dosing on Day 1. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hours post dose on Day 1 and its corresponding standard error has been presented. |
| Secondary | AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 1 | Up to 24 hours post dose on Day 1 | The initial effect of daprodustat and epoetin alfa on HR was compared using AUEC of HR measured by ABPM over 24-hour post dosing. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hours post dose on Day 1 and its corresponding standard error has been presented. |
| Secondary | Average of DBP and MAP Measured by ABPM Over 6-hour Post Dosing on Day 57 | Up to 6 hours post dose on Day 57 | The effect of daprodustat and epoetin alfa on blood pressure was compared using ABPM over 6 hour post-dosing after AC2 on Day 57. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 DBP and MAP, difference between post-HD/pre-AC2 DBP and MAP and post-HD/pre-AC1 DBP and MAP and treatment by difference in post-HD DBP and MAP between AC1 and 2 interaction. LS mean of 6 hour average DBP and MAP post AC2 on Day 57 and its corresponding standard error has been presented. |
| Secondary | Average of HR Measured by ABPM Over 6 Hour Post Dosing on Day 57 | Up to 6 hours post dose on Day 57 | The effect of daprodustat and epoetin alfa on HR was compared using ABPM over 6 hour post-dosing. Analysis was based on ANCOVA with terms for treatment, prior ESA dose (low/high), post-HD/pre-AC1 HR, difference between post-HD/pre-AC2 HR and post-HD/pre-AC1 HR and treatment by difference in post-HD HR between AC1 and 2 interaction. LS mean of 6 hour average HR post AC2 on Day 57 and its corresponding standard error has been presented. |
| Secondary | AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57 | Up to 24 hours post dose on Day 57 | The effect of daprodustat and epoetin alfa on blood pressure was compared using AUEC of SBP, DBP and MAP measured by ABPM over 24-hour post dosing on Day 57. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hour post dose on Day 57 and its corresponding standard error has been presented. |
| Secondary | AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 57 | Up to 24 hours post dose on Day 57 | The effect of daprodustat and epoetin alfa on HR was compared using AUEC of HR measured by ABPM over 24-hour post dosing on Day 57. Analysis was based on ANCOVA with terms for treatment and prior ESA dose (low/high). LS mean of AUEC up to 24 hour post dose on Day 57 and its corresponding standard error has been presented. |
| Secondary | Change From Pre-dose in SBP, DBP and MAP at Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 hours post-dose | The change from pre-dose in SBP, DBP and MAP was measured using ABPM to compare the initial effect of daprodustat to epoetin alfa after AC1 on Day 1. Change from pre-dose at each timepoint is calculated as measurement at post-dose minus pre-acute challenge 1 measurement. |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 registered outcomesOutcomes57
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57 | Up to 6 hours post dose on Day 57 | Intent-to-Treat (ITT)-Population comprised of all randomized participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed. | Millimeters of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | Up to 6 hours post dose on Day 1 | ITT Population. Only those participants with data available at the specified time points were analyzed. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Average of Heart Rate (HR) Measured by ABPM Over 6 Hour Post Dosing on Day 1 | Up to 6 hours post dose on Day 1 | ITT Population. Only those participants with data available at the specified time points were analyzed. | Beats per minute | LEAST_SQUARES_MEAN |
| SECONDARY | Area Under the Effect Curve (AUEC) of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 1 | Up to 24 hours post dose on Day 1 | ITT Population. Only those participants with data available at the specified time points were analyzed. | mmHg*Hours | LEAST_SQUARES_MEAN |
| SECONDARY | AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 1 | Up to 24 hours post dose on Day 1 | ITT Population. Only those participants with data available at the specified time points were analyzed. | Beats per minute*Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Average of DBP and MAP Measured by ABPM Over 6-hour Post Dosing on Day 57 | Up to 6 hours post dose on Day 57 | ITT Population. Only those participants with data available at the specified time points were analyzed. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Average of HR Measured by ABPM Over 6 Hour Post Dosing on Day 57 | Up to 6 hours post dose on Day 57 | ITT Population. Only those participants with data available at the specified time points were analyzed. | Beats per minute | LEAST_SQUARES_MEAN |
| SECONDARY | AUEC of SBP, DBP and MAP Measured by ABPM Over 24-hour Post Dosing on Day 57 | Up to 24 hours post dose on Day 57 | ITT Population. Only those participants with data available at the specified time points were analyzed. | mmHg*Hours | LEAST_SQUARES_MEAN |
| SECONDARY | AUEC of HR Measured by ABPM Over 24-hour Post Dosing on Day 57 | Up to 24 hours post dose on Day 57 | ITT Population. Only those participants with data available at the specified time points were analyzed. | Beats per minute*Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Pre-dose in SBP, DBP and MAP at Day 1 | Day 1: Pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 hours post-dose | ITT-Population. Only those participants with data available at specified time points has been presented (represented as n=X in category titles). | mmHg | MEAN |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 outcomesResults by group1,142
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57 | Daprodustat | 142.87 | Standard Error 3.039 | Millimeters of mercury (mmHg) | |
| Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57 | Recombinant Human Erythropoietin | 143.03 | Standard Error 2.995 | Millimeters of mercury (mmHg) | |
| Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | Daprodustat | SBP | 141.36 | Standard Error 3.115 | mmHg |
| Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | Recombinant Human Erythropoietin | SBP | 142.68 | Standard Error 3.313 | mmHg |
| Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | Daprodustat | DBP | 75.97 | Standard Error 1.253 | mmHg |
| Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | Recombinant Human Erythropoietin | DBP | 77.92 | Standard Error 1.332 | mmHg |
| Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | Daprodustat | MAP | 99.18 | Standard Error 2.212 | mmHg |
| Average of SBP, Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) Measured by ABPM Over 6-hour Post Dosing on Day 1 | Recombinant Human Erythropoietin | MAP | 101.58 | Standard Error 2.351 | mmHg |
| Average of Heart Rate (HR) Measured by ABPM Over 6 Hour Post Dosing on Day 1 | Daprodustat | 70.77 | Standard Error 1.416 | Beats per minute | |
| Average of Heart Rate (HR) Measured by ABPM Over 6 Hour Post Dosing on Day 1 | Recombinant Human Erythropoietin | 73.72 | Standard Error 1.507 | Beats per minute |
1 to 10 of 1,142Source ClinicalTrials.gov
See all 1,142 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Acute Challenge 1 (Day 1) | STARTED | Daprodustat | 45 | |
| Acute Challenge 1 (Day 1) | STARTED | Recombinant Human Erythropoietin | 43 | |
| Acute Challenge 1 (Day 1) | COMPLETED | Daprodustat | 45 | |
| Acute Challenge 1 (Day 1) | COMPLETED | Recombinant Human Erythropoietin | 43 | |
| Acute Challenge 1 (Day 1) | NOT COMPLETED | Daprodustat | 0 | |
| Acute Challenge 1 (Day 1) | NOT COMPLETED | Recombinant Human Erythropoietin | 0 | |
| Hgb Maintenance Phase (8 Weeks) | STARTED | Daprodustat | 45 | |
| Hgb Maintenance Phase (8 Weeks) | STARTED | Recombinant Human Erythropoietin | 43 | |
| Hgb Maintenance Phase (8 Weeks) | COMPLETED | Daprodustat | 32 | |
| Hgb Maintenance Phase (8 Weeks) | COMPLETED | Recombinant Human Erythropoietin | 36 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events80
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 | Headache | Nervous system disorders | Daprodustat | 0 | 45 | 0 |
| other | Headache | Nervous system disorders | Recombinant Human Erythropoietin | 2 | 43 | 2 |
| other | Dizziness | Nervous system disorders | Daprodustat | 1 | 45 | 1 |
| other | Dizziness | Nervous system disorders | Recombinant Human Erythropoietin | 0 | 43 | 0 |
| other | Paraesthesia | Nervous system disorders | Daprodustat | 1 | 45 | 1 |
| other | Paraesthesia | Nervous system disorders | Recombinant Human Erythropoietin | 0 | 43 | 0 |
| other | Presyncope | Nervous system disorders | Daprodustat | 1 | 45 | 2 |
| other | Presyncope | Nervous system disorders | Recombinant Human Erythropoietin | 0 | 43 | 0 |
| other | Gastroenteritis | Infections and infestations | Daprodustat | 1 | 45 | 1 |
| other | Gastroenteritis | Infections and infestations | Recombinant Human Erythropoietin | 0 | 43 | 0 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daprodustat | 0 | 45 |
| Total, all-cause mortality | Recombinant Human Erythropoietin | 0 | 43 |
| Total, other adverse events | Daprodustat | 10 | 45 |
| Total, other adverse events | Recombinant Human Erythropoietin | 4 | 43 |
| Total, serious adverse events | Daprodustat | 10 | 45 |
| Total, serious adverse events | Recombinant Human Erythropoietin | 5 | 43 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36005278 | DERIVED |
Source PubMed
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 Recombinant Human Erythropoietin: Number of Participants With Treatment Emergent Common (>=2%) Non-serious Adverse Events (Non-SAEs) | Trial comparisons |
| Daprodustat vs Recombinant Human Erythropoietin: Number of Participants With Any Serious Adverse Events (SAEs) | Trial comparisons |
| Daprodustat vs Recombinant Human Erythropoietin: deaths from any cause | Trial comparisons |
| Daprodustat vs Recombinant Human Erythropoietin: 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/NCT03029247
GET https://conductscience.org/api/trials/v1/NCT03029247/registered?page=2