deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04155125

A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient

Open-Label Randomised Controlled Trial of Efepoetin Alfa for Treatment of Anaemia Associated With Chronic Kidney Disease Patients Not on Dialysis (ND-CKD). A Non- Inferiority Trial Compared to Methoxy Polyethylene Glycol-Epoetin Beta (MIRCERA)

Sponsor: Novotech (Australia) Pty Limited

Updated 11 times since 2019 Last updated: Dec 21, 2023 Started: Jul 2, 2020 Primary completion: Mar 30, 2022 Completion: Jun 30, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04155125, this PHASE3 trial focuses on Anaemia Associated With Chronic Kidney Disease and remains completed. Sponsored by Novotech (Australia) Pty Limited, it has been updated 11 times since 2020, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Dec 2019 – ~Apr 2020 · 4 months · monthly snapshotNot Yet Recruiting~Apr 2020 – ~Oct 2020 · 6 months · monthly snapshotNot Yet Recruiting~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshotRecruiting~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshotRecruiting~Jan 2021 – ~Sep 2022 · 20 months · monthly snapshotRecruiting~Sep 2022 – ~Jan 2024 · 16 months · monthly snapshotActive Not Recruiting~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshotCompleted~Dec 2025 – present · 7 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Dec 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Jan 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

Show 6 earlier versions
  1. Sep 2022 — Jan 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  2. Jan 2021 — Sep 2022 [monthly]

    Recruiting PHASE3

  3. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  4. Oct 2020 — Dec 2020 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  5. Apr 2020 — Oct 2020 [monthly]

    Not Yet Recruiting PHASE3

  6. Dec 2019 — Apr 2020 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novotech (Australia) Pty Limited
  • PT Kalbe Genexine Biologics
Data source: PT Kalbe Genexine Biologics

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