deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02021318

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa (Dolomites)

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Sponsor: Astellas Pharma Europe B.V.

Conditions Anemia in Chronic Kidney Disease in Non-dialysis Patients
Interventions Darbepoetin alfa Roxadustat
Updated 28 times since 2017 Last updated: Oct 29, 2024 Started: Mar 12, 2014 Primary completion: Mar 23, 2018 Completion: Nov 6, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02021318, this PHASE3 trial focuses on Anemia in Chronic Kidney Disease in Non-dialysis Patients and remains completed. Sponsored by Astellas Pharma Europe B.V., it has been updated 28 times since 2014, 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 – ~Sep 2017 · 7 months · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~May 2018 · 5 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Apr 2020 · 3 months · monthly snapshot~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Jul 2024 · 37 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Sep 2025 · 9 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – present · 5 months · monthly snapshot

Change History

28 versions recorded

  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Feb 2026 [monthly]

    Completed PHASE3

  3. Dec 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Sep 2024 — Dec 2024 [monthly]

    Completed PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

▶ Show 23 earlier versions

  1. Jun 2021 — Jul 2024 [monthly]

    Completed PHASE3

  2. Apr 2021 — Jun 2021 [monthly]

    Completed PHASE3

  3. Jan 2021 — Apr 2021 [monthly]

    Completed PHASE3

  4. Apr 2020 — Jan 2021 [monthly]

    Completed PHASE3

  5. Jan 2020 — Apr 2020 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  6. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE3

  7. Oct 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE3

  8. Sep 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE3

  9. Aug 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE3

  10. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE3

  11. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE3

  12. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE3

  13. Apr 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  14. Mar 2019 — Apr 2019 [monthly]

    Active Not Recruiting PHASE3

  15. Feb 2019 — Mar 2019 [monthly]

    Active Not Recruiting PHASE3

  16. Jan 2019 — Feb 2019 [monthly]

    Active Not Recruiting PHASE3

  17. Nov 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE3

  18. Jun 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE3

  19. May 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  20. Dec 2017 — May 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  21. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  22. Feb 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  23. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Mar 2014

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.
  • Kyntra Bio
Data source: Astellas Pharma Inc

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

Study Locations

Almada, Portugal , Avignon, France , Barcelona, Spain , Belgrade, Serbia , Be’er Ya‘aqov, Israel , Birmingham, United Kingdom , Braga, Portugal , Brest, Belarus , Bucharest, Romania , Budapest, Hungary and 95 more locations