Trial · NCT03457701
Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)
NCT03457701, Phase 2, Completed, GlaxoSmithKline; results first posted 2023-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe). Trials, record NCT03457701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03457701
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)
- NCT number
- NCT03457701
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Anaemia
- Interventions
- Daprodustat, rhEPO, Ferrous sulfate containing the stable iron isotope (57Fe), Ferrous sulfate containing the stable iron isotope (58Fe)
- First posted
- 2018-03-07
- Last updated
- 2024-03-27
- Results first posted
- 2023-07-25
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO | Up to Day 57 | Blood samples were collected at indicated time points for analysis of fractional oral iron absorption following treatment with Daprodustat and rhEPO. Adjusted mean and 95 percent (%) confidence interval (CI) has been presented. |
| Secondary | Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected for measurement of serum iron at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of transferrin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of transferrin saturation at indicated time points. Transferrin saturation was measured as a percentage and is the ratio of serum iron and total iron-binding capacity multiplied by 100. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of soluble transferrin receptor at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of ferritin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The summary of log transformed ration to baseline on markers of iron status for Ferritin is presented here. |
| Secondary | Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of hepcidin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The summary of log transformed ration to baseline on markers of iron status for Hepcidin is presented here. |
| Secondary | Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of erythroferrone at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of hemoglobin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
| Secondary | Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Blood samples were collected from participants for measurement of hematocrit at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO | Up to Day 57 | Evaluable Population consisted of all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. | Percentage (%) of iron absorbed | MEAN |
| SECONDARY | Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed. | Micromoles per liter (umol/L) | MEAN |
| SECONDARY | Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed. | Gram per Liter (g/L) | MEAN |
| SECONDARY | Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed. | Percentage (%) of transferrin saturation | MEAN |
| SECONDARY | Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed. | Milligrams per liter (mg/L) | MEAN |
| SECONDARY | Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed. | Microgram per liter (ug/L) | GEOMETRIC_MEAN |
| SECONDARY | Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed. | Microgram per liter (ug/L) | GEOMETRIC_MEAN |
| SECONDARY | Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed. | Microgram per liter (ug/L) | MEAN |
| SECONDARY | Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed. | Grams per liter (g/L) | MEAN |
| SECONDARY | Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO | Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days) | Evaluable Population that included all randomized participants who received study medication and completed the iron absorption assessment for both treatment periods. Only those participants with data available at the specified data points were analyzed. | Proportion of red blood cells in blood | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO | Daprodustat | 20.64 | 95% Confidence Interval 10.96 to 30.32 | Percentage (%) of iron absorbed | |
| Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO | rhEPO | 20.62 | 95% Confidence Interval 10.95 to 30.30 | Percentage (%) of iron absorbed | |
| Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO | Daprodustat | Period 1, DAY 14 | -1.5 | Standard Deviation 6.72 | Micromoles per liter (umol/L) |
| Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO | rhEPO | Period 1, DAY 14 | 1.7 | Standard Deviation 4.93 | Micromoles per liter (umol/L) |
| Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO | Daprodustat | Period 1, DAY 28 | 2.5 | Standard Deviation 8.96 | Micromoles per liter (umol/L) |
| Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO | rhEPO | Period 1, DAY 28 | 3.3 | Standard Deviation 5.47 | Micromoles per liter (umol/L) |
| Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO | Daprodustat | Period 2, DAY 14 | -1.3 | Standard Deviation 4.93 | Micromoles per liter (umol/L) |
| Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO | rhEPO | Period 2, DAY 14 | -3.5 | Standard Deviation 6.66 | Micromoles per liter (umol/L) |
| Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO | Daprodustat | Period 2, DAY 28 | -2.2 | Standard Deviation 4.79 | Micromoles per liter (umol/L) |
| Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO | rhEPO | Period 2, DAY 28 | -3.3 | Standard Deviation 5.01 | Micromoles per liter (umol/L) |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (up to Day 28) | STARTED | Daprodustat Followed by rhEPO | 7 | |
| Treatment Period 1 (up to Day 28) | STARTED | rhEPO Followed by Daprodustat | 8 | |
| Treatment Period 1 (up to Day 28) | Safety Population | Daprodustat Followed by rhEPO | 7 | |
| Treatment Period 1 (up to Day 28) | Safety Population | rhEPO Followed by Daprodustat | 7 | |
| Treatment Period 1 (up to Day 28) | COMPLETED | Daprodustat Followed by rhEPO | 6 | |
| Treatment Period 1 (up to Day 28) | COMPLETED | rhEPO Followed by Daprodustat | 7 | |
| Treatment Period 1 (up to Day 28) | NOT COMPLETED | Daprodustat Followed by rhEPO | 1 | |
| Treatment Period 1 (up to Day 28) | NOT COMPLETED | rhEPO Followed by Daprodustat | 1 | |
| Treatment Period 2 (Up to Day 28) | STARTED | Daprodustat Followed by rhEPO | 6 | |
| Treatment Period 2 (Up to Day 28) | STARTED | rhEPO Followed by Daprodustat | 7 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events88
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 | Hypoacusis | Ear and labyrinth disorders | Daprodustat in Period 1 | 0 | 7 | 0 |
| other | Hypoacusis | Ear and labyrinth disorders | rhEPO in Period 1 | 1 | 7 | 1 |
| other | Hypoacusis | Ear and labyrinth disorders | rhEPO in Period 2 | 0 | 7 | 0 |
| other | Hypoacusis | Ear and labyrinth disorders | Daprodustat in Period 2 | 0 | 7 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Daprodustat in Period 1 | 0 | 7 | 0 |
| other | Vertigo | Ear and labyrinth disorders | rhEPO in Period 1 | 1 | 7 | 1 |
| other | Vertigo | Ear and labyrinth disorders | rhEPO in Period 2 | 0 | 7 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Daprodustat in Period 2 | 0 | 7 | 0 |
| other | Retinal haemorrhage | Eye disorders | Daprodustat in Period 1 | 1 | 7 | 1 |
| other | Retinal haemorrhage | Eye disorders | rhEPO in Period 1 | 0 | 7 | 0 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daprodustat in Period 1 | 0 | 7 |
| Total, all-cause mortality | rhEPO in Period 1 | 0 | 7 |
| Total, all-cause mortality | rhEPO in Period 2 | 0 | 7 |
| Total, all-cause mortality | Daprodustat in Period 2 | 0 | 7 |
| Total, other adverse events | Daprodustat in Period 1 | 3 | 7 |
| Total, other adverse events | rhEPO in Period 1 | 3 | 7 |
| Total, other adverse events | rhEPO in Period 2 | 2 | 7 |
| Total, other adverse events | Daprodustat in Period 2 | 3 | 7 |
| Total, serious adverse events | Daprodustat in Period 1 | 0 | 7 |
| Total, serious adverse events | rhEPO in Period 1 | 1 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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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