deltatrials
Completed PHASE3 NCT01102413

Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

Sponsor: Pharmacosmos A/S

Updated 9 times since 2017 Last updated: Nov 2, 2015 Started: Apr 30, 2010 Primary completion: Jun 30, 2014 Completion: Jun 30, 2014

This PHASE3 trial investigates Chronic Kidney Disease and Iron Deficiency Anemia and is currently completed. Pharmacosmos A/S leads this study, which shows 9 recorded versions since 2010 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

Show 4 earlier versions
  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE3

  2. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  3. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Apr 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pharmacosmos A/S
Data source: Pharmacosmos A/S

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

Study Locations