deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01887600

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis (ALPS)

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat for 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 Placebo Roxadustat
Updated 16 times since 2017 Last updated: Oct 29, 2024 Started: Sep 3, 2013 Primary completion: Nov 1, 2017 Completion: Nov 1, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Anemia in Chronic Kidney Disease in Non-dialysis Patients and is currently completed. Astellas Pharma Europe B.V. leads this study, which shows 16 recorded versions since 2013 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Nov 2017 · 5 months · monthly snapshot~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Nov 2019 · 12 months · monthly snapshot~Nov 2019 – ~Mar 2020 · 4 months · monthly snapshot~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Jul 2024 · 40 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

16 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 11 earlier versions

  1. Mar 2021 — Jul 2024 [monthly]

    Completed PHASE3

  2. Jan 2021 — Mar 2021 [monthly]

    Completed PHASE3

  3. Mar 2020 — Jan 2021 [monthly]

    Completed PHASE3

  4. Nov 2019 — Mar 2020 [monthly]

    Completed PHASE3

  5. Nov 2018 — Nov 2019 [monthly]

    Completed PHASE3

  6. Jun 2018 — Nov 2018 [monthly]

    Completed PHASE3

  7. Dec 2017 — Jun 2018 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  8. Nov 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE3

  9. Jun 2017 — Nov 2017 [monthly]

    Active Not Recruiting PHASE3

  10. Feb 2017 — Jun 2017 [monthly]

    Active Not Recruiting PHASE3

  11. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Sep 2013

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

Alcorcón, Spain , Ankara, Turkey (Türkiye) , Antwerp, Belgium , Badalona-Barcelona, Spain , Barcelona, Spain , Bari, Italy , Barranquilla, Colombia , Baudour, Belgium , Belgrade, Serbia , Bloemfontein, South Africa and 94 more locations