Trial · NCT04655027
A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
NCT04655027, Phase 4, Completed, AstraZeneca; results first posted 2024-04-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD). Trials, record NCT04655027. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04655027
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
- NCT number
- NCT04655027
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 25 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Anemia of Chronic Kidney Disease
- Interventions
- Roxadustat, rHuEPO
- First posted
- 2020-12-04
- Last updated
- 2024-04-22
- Results first posted
- 2024-04-22
- Limitations and caveats
* NDD randomization strata were merged because recruitment was insufficient.~* The log-transform of AUC was removed from the primary assessment post-database-lock when negative AUC were discovered (which invalidated log-transformation).
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) | From Baseline (Day 1) to Day 15 | The main effect of roxadustat versus rHuEPO on GI iron absorption was evaluated. |
| Secondary | Difference From Baseline to Day 15 in Area Under Curve (AUC) of Iron Absorption (0-3 Hours) | From Baseline (Day 1) to Day 15 | The effect and interaction with key baseline variables of roxadustat versus rHuEPO on iron absorption was assessed. |
| Secondary | Difference From Baseline to Day 15 in Serum Iron | From baseline (Day 1) to Day 15 | The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: serum iron was assessed. |
| Secondary | Difference From Baseline to Day 15 in Ferritin | From baseline (Day 1) to Day 15 | The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Ferritin was assessed. |
| Secondary | Difference From Baseline to Day 15 in Total Iron Binding Capacity (TIBC) | From baseline (Day 1) to Day 15 | The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TIBC was assessed. |
| Secondary | Relative Difference From Baseline to Day 15 in Transferrin Saturation (TSAT) | From baseline (Day 1) to Day 15 | The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TSAT (fraction of TIBC) was assessed. |
| Secondary | Difference From Baseline to Day 15 in Transferrin | From baseline (Day 1) to Day 15 | The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Transferrin was assessed. |
| Secondary | Difference From Baseline to Day 15 in Soluble Transferrin Receptor | From baseline (Day 1) to Day 15 | The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Soluble transferrin receptor was assessed. |
| Secondary | Difference From Baseline to Day 15 in Hepcidin | From baseline (Day 1) to Day 15 | The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of Hepcidin was assessed. |
| Secondary | Number of Subjects With Adverse Events (AEs) | From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks) | AEs as variables of safety was assessed. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) | From Baseline (Day 1) to Day 15 | The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis.~Here, the number analyzed signified only the subjects with available data that were evaluated on that specific group. | gram*3hours/deciliter (g*3hr/dL) | MEAN |
| SECONDARY | Difference From Baseline to Day 15 in Area Under Curve (AUC) of Iron Absorption (0-3 Hours) | From Baseline (Day 1) to Day 15 | The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis.~Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure.~The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing. | gram*3hours/deciliter (g*3hr/dL) | MEAN |
| SECONDARY | Difference From Baseline to Day 15 in Serum Iron | From baseline (Day 1) to Day 15 | The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis.~Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure.~The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing. | micromole/Liter (µmol/L) | MEAN |
| SECONDARY | Difference From Baseline to Day 15 in Ferritin | From baseline (Day 1) to Day 15 | The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis.~Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure.~The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing. | microgram/Liter (µg/L) | MEAN |
| SECONDARY | Difference From Baseline to Day 15 in Total Iron Binding Capacity (TIBC) | From baseline (Day 1) to Day 15 | The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis.~Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure.~The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing. | micromole/Liter (µmol/L) | MEAN |
| SECONDARY | Relative Difference From Baseline to Day 15 in Transferrin Saturation (TSAT) | From baseline (Day 1) to Day 15 | The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis.~Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure.~The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing. | Ratio | MEAN |
| SECONDARY | Difference From Baseline to Day 15 in Transferrin | From baseline (Day 1) to Day 15 | The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis.~Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure.~The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing. | gram/Liter (g/L) | MEAN |
| SECONDARY | Difference From Baseline to Day 15 in Soluble Transferrin Receptor | From baseline (Day 1) to Day 15 | The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis.~Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure.~The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing. | milligram/Liter (mg/L) | MEAN |
| SECONDARY | Difference From Baseline to Day 15 in Hepcidin | From baseline (Day 1) to Day 15 | The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis.~Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure.~The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing. | microgram/Liter (µg/L) | MEAN |
| SECONDARY | Number of Subjects With Adverse Events (AEs) | From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks) | The Safety analysis set included all randomized patients who received at least 1 dose of study treatment, with patients being analyzed as treated, rather than as randomized. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) | Roxadustat | Change from baseline | 11.288 | Standard Deviation 28.1506 | gram*3hours/deciliter (g*3hr/dL) |
| Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) | rHuEPO | Change from baseline | -0.259 | Standard Deviation 9.7369 | gram*3hours/deciliter (g*3hr/dL) |
| Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) | Roxadustat | Hemodialysis (HD) group- Change from baseline | 20.125 | Standard Deviation 29.9536 | gram*3hours/deciliter (g*3hr/dL) |
| Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) | rHuEPO | Hemodialysis (HD) group- Change from baseline | -1.625 | Standard Deviation 10.2189 | gram*3hours/deciliter (g*3hr/dL) |
| Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) | Roxadustat | Peritoneal dialysis (PD)- Change from baseline | -2.408 | Standard Deviation 19.4973 | gram*3hours/deciliter (g*3hr/dL) |
| Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) | rHuEPO | Peritoneal dialysis (PD)- Change from baseline | -2.263 | Standard Deviation 6.7321 | gram*3hours/deciliter (g*3hr/dL) |
| Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) | Roxadustat | Non-dialysis-dependent (NDD)- Change from baseline | 34.700 | Standard Deviation 39.8808 | gram*3hours/deciliter (g*3hr/dL) |
| Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) | rHuEPO | Non-dialysis-dependent (NDD)- Change from baseline | 15.950 | Standard Deviation NA | gram*3hours/deciliter (g*3hr/dL) |
| Difference From Baseline to Day 15 in Area Under Curve (AUC) of Iron Absorption (0-3 Hours) | Roxadustat | 11.288 | Standard Deviation 28.1506 | gram*3hours/deciliter (g*3hr/dL) | |
| Difference From Baseline to Day 15 in Area Under Curve (AUC) of Iron Absorption (0-3 Hours) | rHuEPO | -0.259 | Standard Deviation 9.7369 | gram*3hours/deciliter (g*3hr/dL) |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Roxadustat | 13 | |
| Overall Study | STARTED | rHuEPO | 12 | |
| Overall Study | COMPLETED | Roxadustat | 12 | |
| Overall Study | COMPLETED | rHuEPO | 12 | |
| Overall Study | NOT COMPLETED | Roxadustat | 1 | |
| Overall Study | NOT COMPLETED | rHuEPO | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Abdominal infection | Infections and infestations | Roxadustat | 1 | 13 | |
| other | Abdominal infection | Infections and infestations | rHuEPO | 0 | 12 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Roxadustat | 1 | 13 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | rHuEPO | 2 | 12 | |
| other | Hypermagnesaemia | Metabolism and nutrition disorders | Roxadustat | 1 | 13 | |
| other | Hypermagnesaemia | Metabolism and nutrition disorders | rHuEPO | 0 | 12 | |
| other | Seizure | Nervous system disorders | Roxadustat | 1 | 13 | |
| other | Seizure | Nervous system disorders | rHuEPO | 0 | 12 | |
| other | Open angle glaucoma | Eye disorders | Roxadustat | 1 | 13 | |
| other | Open angle glaucoma | Eye disorders | rHuEPO | 0 | 12 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Roxadustat | 0 | 13 |
| Total, all-cause mortality | rHuEPO | 0 | 12 |
| Total, other adverse events | Roxadustat | 5 | 13 |
| Total, other adverse events | rHuEPO | 2 | 12 |
| Total, serious adverse events | Roxadustat | 0 | 13 |
| Total, serious adverse events | rHuEPO | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38280066 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Roxadustat vs rHuEPO: deaths from any cause | Trial comparisons |
| Roxadustat vs rHuEPO: 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/NCT04655027
GET https://conductscience.org/api/trials/v1/NCT04655027/results?page=2