Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia
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Phase
—
Status
Completed
Study type
Observational
Enrollment
2,104actual
Sites
47
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-06-01 | actual | When the study began enrolling |
| Primary completion | 2025-06-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-23 | actual | The whole study's end, after follow-up |
| First posted | 2020-05-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-07-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Renal Anemia
Intervention
- Drug: Roxadustat — also filed as ASP1517, Evrenzo
Primary outcomes
what the primary-completion date above is the date OFProportion of participants with Adverse Drug Reactions (ADR)
measured Up to Week 104
Proportion of participants with serious ADR
measured Up to Week 104
Proportion of participants with thromboembolism
measured Up to Week 104
Proportion of participants with hypertension
measured Up to Week 104
Proportion of participants with hepatic function disorder
measured Up to Week 104
Proportion of participants with malignant tumors
measured Up to Week 104
Proportion of participants with retinal hemorrhage
measured Up to Week 104
Proportion of Participants With Seizures
measured Up to week 104
Proportion of Participants With Serious Infection
measured Up to week 104
Proportion of Participants With Central Hypothyroidsm
measured Up to Week 104
Proportion of participants with myopathy events
measured Up to Week 104
Proportion of Participants With Renal Function Disorder
measured Up to week 104
Proportion of participants with ADR within 4 weeks after switching to roxadustat
measured Up to Week 4
Proportion of participants with ADR with high doses of roxadustat
measured Up to Week 104
Change from baseline in Hemoglobin (Hb) levels
measured Up to Week 104
Mean value of Hb levels over time
measured Up to Week 104
Achievement rate for target Hb level
measured Up to Week 104
Mean Hb levels at 4 weeks after switching to roxadustat
measured At Week 4
Publications
- PMID 39899733 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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