Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease
Open-Label Extension Study to Evaluate the Efficacy and Safety of FG-4592 for the Long-Term Maintenance Treatment of Anemia in Dialysis and Non-Dialysis Patients With Chronic Kidney Disease
Sponsor: Astellas Pharma Inc
Listed as NCT01630889, this PHASE2 trial focuses on Anemia and Chronic Kidney Disease and remains completed. Sponsored by Astellas Pharma Inc, it has been updated 10 times since 2012, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
10 versions recorded-
Feb 2026 — Present [monthly]
Completed PHASE2
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Sep 2024 — Feb 2026 [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Oct 2021 — Jul 2024 [monthly]
Completed PHASE2
Phase: PHASE2_PHASE3 → PHASE2
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Jan 2021 — Oct 2021 [monthly]
Completed PHASE2_PHASE3
▶ Show 5 earlier versions
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Jul 2020 — Jan 2021 [monthly]
Completed PHASE2_PHASE3
Status: Unknown Status → Completed
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Jan 2019 — Jul 2020 [monthly]
Unknown Status PHASE2_PHASE3
Status: Enrolling By Invitation → Unknown Status
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Jun 2018 — Jan 2019 [monthly]
Enrolling By Invitation PHASE2_PHASE3
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Feb 2017 — Jun 2018 [monthly]
Enrolling By Invitation PHASE2_PHASE3
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Jan 2017 — Feb 2017 [monthly]
Enrolling By Invitation PHASE2_PHASE3
First recorded
May 2012
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Astellas Pharma Inc
- AstraZeneca
- Kyntra Bio
For direct contact, visit the study record on ClinicalTrials.gov .