A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D
A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With Intravenous Iron Sucrose in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)
Sponsor: Pharmacosmos A/S
This PHASE3 trial investigates Chronic Kidney Disease Stage 5 (Dialysis Dependent) and is currently completed. Pharmacosmos A/S leads this study, which shows 8 recorded versions since 2011 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
8 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2023 — Jul 2024 [monthly]
Completed PHASE3
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE3
-
Jan 2021 — Dec 2022 [monthly]
Completed PHASE3
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Jun 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Pharmacosmos A/S
For direct contact, visit the study record on ClinicalTrials.gov .