deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02273726

Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis

A Phase 3, Open-Label, Randomized, Active-Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) in the Maintenance Treatment of Anemia in Subjects With End Stage Renal Disease (ESRD) on Stable Dialysis

Sponsor: Astellas Pharma Europe B.V.

Updated 14 times since 2017 Last updated: Sep 30, 2021 Started: Jan 15, 2015 Primary completion: Sep 19, 2018 Completion: Sep 19, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02273726, this PHASE3 trial focuses on CKD Anemia in Stable Dialysis Patients and remains completed. Sponsored by Astellas Pharma Europe B.V., it has been updated 14 times since 2015, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Jul 2017 · 2 months · monthly snapshot~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~May 2019 · 9 months · monthly snapshot~May 2019 – ~Dec 2019 · 7 months · monthly snapshot~Dec 2019 – ~Jan 2021 · 13 months · monthly snapshot~Jan 2021 – ~Nov 2021 · 10 months · monthly snapshot~Nov 2021 – ~Jul 2024 · 32 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – present · 5 months · monthly snapshot

Change History

14 versions recorded
  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Feb 2026 [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Nov 2021 — Jul 2024 [monthly]

    Completed PHASE3

Show 9 earlier versions
  1. Jan 2021 — Nov 2021 [monthly]

    Completed PHASE3

  2. Dec 2019 — Jan 2021 [monthly]

    Completed PHASE3

  3. May 2019 — Dec 2019 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Aug 2018 — May 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  5. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

  6. Jul 2017 — Jun 2018 [monthly]

    Recruiting PHASE3

  7. May 2017 — Jul 2017 [monthly]

    Recruiting PHASE3

  8. Feb 2017 — May 2017 [monthly]

    Recruiting PHASE3

  9. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Jan 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Astellas Pharma Europe B.V.
  • AstraZeneca
  • Kyntra Bio
Data source: Kyntra Bio

For direct contact, visit the study record on ClinicalTrials.gov .