Iron isomaltoside 1000
Trials 37 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03013439 | Jan → Jun 2017 | iron deficiency anemia, iron metabolism disease | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05913414 | May 2023 → May 2024 | iron deficiency anemia, nasopharyngeal carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05299411 | Apr 2023 → Mar 2025 | chemotherapy-induced toxicity, colon carcinoma | Korea University Guro Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02484768 | Jan → Feb 2015 | restless legs syndrome | Pharmacosmos A/S | Withdrawn | No outcome recorded |
| Phase 317 trials | ||||||
| Phase 3 | NCT06884280 | Nov 2025 → Oct 2027 expected | iron deficiency anemia | Hull University Teaching Hospitals NHS Trust | Recruiting | No outcome recorded |
| Phase 3 | NCT06248749 | Feb 2024 → Dec 2028 expected | anemia | University of Saskatchewan | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03957057 | Sep 2020 → Apr 2022 | deficiency anemia, iron deficiency anemia | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 3 | NCT03238911 | Oct 2017 → Jun 2018 | iron deficiency anemia | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT02972294 | Mar 2017 → Sep 2021 | anemia, bone disorder | University Hospital, Angers | Terminated | No outcome recorded |
| Phase 3 | NCT02130063 | May 2014 → Aug 2015 | iron deficiency anemia | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT01895231 | Jun 2013 → Dec 2016 | iron deficiency anemia | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT01895218 | Jun 2013 → Dec 2014 | — | 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 | NCT01145638 | Oct 2010 → Apr 2014 | chemotherapy-induced toxicity, neoplasm | 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 | NCT00537186 | Jun 2007 → Jul 2008 | congestive heart failure | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT00536666 | May 2007 → Aug 2008 | chronic kidney disease, iron deficiency anemia | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT02172001 | ? → Mar 2015 | iron deficiency anemia | Pharmacosmos A/S | Withdrawn | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT06830941 | Feb 2025 → Feb 2027 expected | anemia | Xie Jingyuan, MD | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06350955 | May 2024 → Jun 2026 overdue | hypophosphatemia | Lucie Favre | Recruiting | No outcome recorded |
| Phase 4 | NCT05719376 | Feb 2023 → May 2026 | chronic renal failure syndrome | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT05358509 | Mar 2021 → Dec 2023 | iron deficiency anemia | Thomas Jefferson University | Completed | No outcome recorded |
| Phase 4 | NCT04505514 | Aug 2020 → Oct 2022 | anemia | University of Malaya | Unknown | No outcome recorded |
| Phase 4 | NCT04346004 | Apr 2020 → Mar 2023 | aortic valve stenosis | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT03466983 | May 2018 → May 2020 | inflammatory bowel disease | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 4 | NCT03229954 | Aug 2017 → Apr 2019 | postgastrectomy syndrome | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT02632760 | Jul 2016 → Apr 2024 | anemia | Bayside Health | Completed | No outcome recorded |
| Phase 4 | NCT02905539 | Jul 2016 → Jun 2020 | iron deficiency anemia | Saarland University | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07236788 | Mar 2025 → Dec 2026 expected | iron deficiency anemia, obesity disorder | China-Japan Friendship Hospital | Recruiting | No outcome recorded |
| — | NCT03610230 | Feb 2019 → Mar 2021 | iron deficiency anemia | The University of Hong Kong | Terminated | No outcome recorded |
| — | NCT03470649 | Mar 2018 → Apr 2019 | anemia, arthropathy | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT03094182 | Mar 2017 → Aug 2019 | — | Yonsei University | Unknown | No outcome recorded |
| — | 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 |
Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04061655 Comparator | Sep 2019 → Jan 2020 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT01280240 Comparator | Mar → Sep 2012 | chemotherapy-induced toxicity | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 1 | NCT01213992 Comparator | Mar → Oct 2012 | chronic kidney disease | 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 | NCT01213979 Comparator | Feb → May 2012 | — | 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 21 trial | ||||||
| Phase 2 | NCT04206228 Comparator | Jan 2020 → Feb 2022 | aortic valve stenosis, disorder of iron metabolism and transport | Oslo University Hospital | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03662789 Comparator | Apr 2018 → Feb 2020 | — | Oslo University Hospital | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT03565354 Comparator | Jul 2018 → Jun 2020 | colorectal cancer, iron deficiency anemia | Prince of Wales Hospital, Shatin, Hong Kong | 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 43 trials | ||||||
| Phase 4 | NCT05804071 Comparator | Mar 2023 → Jan 2024 | iron deficiency anemia, iron metabolism disease | Qianfoshan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02999217 Comparator | Oct 2016 → Oct 2017 | colorectal neoplasm, iron deficiency anemia | Kaunas University of Medicine | Unknown | 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 |
| Phase not applicable2 trials | ||||||
| — | 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 11 cited values
Every value below carries the sentence it was read from. 56 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)” NCT06884280 ↗ “Monofer (iron isomaltoside 1000)” NCT01213680 ↗ |
| Known as | ferric derisomaltose | “OBJECTIVE: To compare risks of hypophosphatemia and effects on biomarkers of mineral and bone homeostasis of intravenous iron isomaltoside (now known as ferric derisomaltose)...” PMID 32016310 ↗ Feb 2020 |
| Known as | IIM | “The HiFIT study is a multicentre, 2×2 factorial, randomised, double-blinded, controlled trial evaluating the effect of iron isomaltoside (IIM) (20 mg/kg) vs placebo and of TXA...” PMID 33455926 ↗ Jan 2021 |
| Known as | iron isomaltoside | “2.1Intravenous iron supplement：Iron Isomaltoside Injection（5ml： 500mg，Wasserburger Arzneimittelwerk GmbH）,Intravenous iron supplement” NCT05804071 ↗24“Iron Sucrose, Iron Gluconate or Iron Isomaltoside (Treatment group A) versus No Iron Infusion treatment” NCT06248749 ↗ “ferric carboxymaltose 1000 mg or Iron isomaltoside 1000 mg given Intravenously” NCT02632760 ↗ “Monofer (iron isomaltoside)” NCT05719376 ↗ “Drug: Iron isomaltoside” NCT06350955 ↗ |
| Known as | Iron oligosaccharide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00537186 ↗ |
| 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 ↗25“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 ↗ “Intravenous Iron-induced Hypophosphatemia in Patients With Roux-en-Y Gastric Bypass: a Single-blind, Randomized Clinical Trial Comparing Iron Isomaltoside (Monofer®) and Ferric...” NCT06350955 ↗ “The investigators examined the effect of intravenous iron isomaltoside (Monofer®) administration on postoperative anemia and transfusion requirements in patients undergoing...” NCT03470649 ↗ “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®) consists of iron with a tighter binding to its carbohydrate moiety with less free iron” NCT03610230 ↗ “Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease” NCT01599702 ↗ “Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)” NCT03013439 ↗ “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 ↗ “iron isomaltoside (Monofer, Monoferric) ferric gluconate (FG) iron sucrose (IS)” NCT06248749 ↗ “The drug, iron isomaltoside (Monofer), will be infused one single high dose” NCT03229954 ↗ “Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo” NCT02172001 ↗ “Iron isomaltoside 1000 (Monofer®) - Intravenous Infusion” NCT01563367 ↗ “iron isomaltoside 1000 (Monofer®)” NCT02130063 ↗ “Iron Isomaltoside 1000 (Monofer®)” NCT01410435 ↗ “Drug: iron isomaltoside(Monofer®)” NCT03565354 ↗ “iron isomaltoside (Monofer®)” NCT03957057 ↗ |
| Known as | Monofer(R) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01280240 ↗ |
| Known as | Monoferric | “iron isomaltoside (Monofer, Monoferric) ferric gluconate (FG) iron sucrose (IS)” NCT06248749 ↗ |
| Modality | Other / unclassified | “Intravenous Iron Oligosaccharide” NCT01017614 ↗ |
| Route | Intravenous | “given either as repeated IV boluses or as total dose infusion” NCT00536666 ↗ |