Iron isomaltoside 1000
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT05913414 | May 2023 → May 2024 | iron deficiency anemia, nasopharyngeal carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT02484768 | Jan → Feb 2015 | restless legs syndrome | Pharmacosmos A/S | Withdrawn | No outcome recorded |
| Phase 310 trials · 1 met primary | ||||||
| Phase 3 | NCT06884280 | Nov 2025 → Oct 2027 expected | iron deficiency anemia | Hull University Teaching Hospitals NHS Trust | Recruiting | No outcome recorded |
| Phase 3 | NCT02130063 | May 2014 → Aug 2015 | iron deficiency anemia | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT01895218 | Jun 2013 → Dec 2014 | — | Pharmacosmos A/S | Completed | Met primary |
| Phase 3 | NCT01895231 | Jun 2013 → Dec 2016 | iron deficiency anemia | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT01895205 | Jun 2013 → Aug 2015 | — | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT01599702 | May 2012 → Dec 2014 | inflammatory bowel disease | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT01410435 | Jun 2011 → Aug 2013 | anemia, inflammatory bowel disease | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT01102413 | Apr 2010 → Jun 2014 | chronic kidney disease, iron deficiency anemia | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT01017614 | Oct 2009 → Jul 2012 | inflammatory bowel disease | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT02172001 | ? → Mar 2015 | iron deficiency anemia | Pharmacosmos A/S | Withdrawn | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05719376 | Feb 2023 → May 2026 | chronic renal failure syndrome | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT02905539 | Jul 2016 → Jun 2020 | iron deficiency anemia | Saarland University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02862665 | Aug 2016 → May 2020 | cardiac valvular defect | Yonsei University | Completed | No outcome recorded |
| — | NCT01628770 | May → Dec 2012 | — | Dow University of Health Sciences | Completed | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT01213992 Comparator | Mar → Oct 2012 | chronic kidney disease | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 1 | NCT01213979 Comparator | Feb → May 2012 | — | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 1 | NCT01213680 Comparator | Feb → Aug 2012 | inflammatory bowel disease | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 1 | NCT01469078 Comparator | Oct 2011 → Apr 2012 | chronic kidney disease | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 2/3 | NCT03662789 Comparator | Apr 2018 → Feb 2020 | — | Oslo University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01563367 Comparator | Jan 2012 → Aug 2013 | — | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT01222884 Comparator | Jun 2011 → Oct 2013 | end stage renal failure | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 4 | NCT01927328 Comparator | Aug 2013 → Aug 2017 | anemia, esophageal adenocarcinoma, gastric adenocarcinoma | Nottingham University Hospitals NHS Trust | Unknown | No outcome recorded |
| — | NCT05581420 Comparator | Jun 2022 → May 2025 | inflammatory bowel disease | Leiden University Medical Center | Unknown | No outcome recorded |
| — | NCT03888768 Comparator | Aug 2019 → Oct 2021 | iron deficiency anemia | Ministry of Health, Malaysia | Unknown | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | iron isomaltoside 1000 | “The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic...” NCT01469078 ↗21“Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection” NCT01222884 ↗ “Intravenous Iron Isomaltoside 1000 (Monofer®)” NCT01102413 ↗ “Iron Isomaltoside 1000 (Monofer®)” NCT01410435 ↗ “Monofer (iron isomaltoside 1000)” NCT01213680 ↗ “Monofer (iron isomaltoside 1000)” NCT06884280 ↗ |
| Known as | iron isomaltoside | “Monofer (iron isomaltoside)” NCT05719376 ↗ |
| Known as | IVFe | “214 patients undergoing reoperation or multiple valve surgery are randomly allocated to either the iron isomaltoside 1000 (IVFe) or the control group from August 2016 to August 2018.” PMID 29973224 ↗ Jul 2018 |
| Known as | Monofer | “Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-Dialysis...” NCT01213992 ↗17“The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic...” NCT01469078 ↗ “The patients will receive iron isomaltoside 1000 (Monofer®) as an i.v. infusion of 1000 mg (diluted with normal saline, 10 mg/ml) twice; 3 days before surgery and 3 days after surgery.” NCT02862665 ↗ “Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease” NCT01599702 ↗ “Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion” NCT01213979 ↗ “Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions” NCT01895205 ↗ “Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo” NCT02172001 ↗ “Iron isomaltoside 1000 (Monofer®) - Intravenous Infusion” NCT01563367 ↗ “Iron Isomaltoside 1000 (Monofer®)” NCT01410435 ↗ “iron isomaltoside 1000 (Monofer®)” NCT02130063 ↗ |
| Modality | Other / unclassified | “Intravenous Iron Oligosaccharide” NCT01017614 ↗ |
| Route | Intravenous | “administered as intravenous infusions” NCT01017614 ↗ |