Trial reportScandinavian journal of gastroenterology2016
High-dose fast infusion of parenteral iron isomaltoside is efficacious in inflammatory bowel disease patients with iron-deficiency anaemia without profound changes in phosphate or fibroblast growth factor 23.
Trial report in Scandinavian journal of gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- Comparison of iron isomaltoside ferumoxytol with iron sucrose for iron deficiency anemia: a meta-analysis of randomized controlled trials.African health sciences · 2023Pooled it
- Hypophosphataemia after treatment of iron deficiency with intravenous ferric carboxymaltose or iron isomaltoside-a systematic review and meta-analysis.British journal of clinical pharmacology · 2021Pooled it
- Characterization of serum phosphate levels over time with intravenous ferric carboxymaltose versus placebo as treatment for heart failure with reduced ejection fraction and iron deficiency: An exploratory prospective substudy from HEART-FID.European journal of heart failure · 2025Trial
- Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021Trial
- Trial
- A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial.American journal of hematology · 2019Trial
- A randomized trial of iron isomaltoside versus iron sucrose in patients with iron deficiency anemia.American journal of hematology · 2017Trial
- Intravenous iron in ulcerative colitis-Raising the (iron) bar.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026Article
- Preoperative Iron Isomaltoside administration enhances postoperative anemia recovery in robotic pancreatic surgery.Journal of robotic surgery · 2026Article
- Prevalence and Risk Factors of Anemia in Inflammatory Bowel Diseases: A Case-Control Study.Cureus · 2023Article
- Effect of Intravenous Iron Administration on Bone Mineral and Iron Homeostasis in Patients with Inflammatory Bowel Disease-Results of a Prospective Single-Centre Study.Journal of personalized medicine · 2023Article
- High-Dose Intravenous Iron with Either Ferric Carboxymaltose or Ferric Derisomaltose: A Benefit-Risk Assessment.Drug safety · 2022Article
- Real-world evaluation of an intravenous iron service for the treatment of iron deficiency in patients with gastroenterological disorders.Frontline gastroenterology · 2021Article
- Hypophosphataemia, fibroblast growth factor 23 and third-generation intravenous iron compounds: a narrative review.Drugs in context · 2021Review
- Hypophosphataemia after ferric carboxymaltose is unrelated to symptoms, intestinal inflammation or vitamin D status.BMC gastroenterology · 2020Observational
- Response: An Economic Evaluation of Iron Isomaltoside 1000 Versus Ferric Carboxymaltose in Patients with Inflammatory Bowel Disease and Iron Deficiency Anemia in Denmark.Advances in therapy · 2019Article
- Intravenous Irons: From Basic Science to Clinical Practice.Pharmaceuticals (Basel, Switzerland) · 2018Review
- Management of Anemia in Patients with Inflammatory Bowel Disease (IBD).Current treatment options in gastroenterology · 2018Review
- The NIMO Scandinavian Study: A Prospective Observational Study of Iron Isomaltoside Treatment in Patients with Iron Deficiency.Gastroenterology research and practice · 2017Article
- Safety of intravenous iron use in chronic kidney disease.Current opinion in nephrology and hypertension · 2016Review
Corrections and comments
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Authors and funding
6 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveIron isomaltoside (Monofer(®)) is a high-dose intravenous iron preparation with good tolerability and efficacy in inflammatory bowel disease (IBD) patients with iron deficiency anaemia (IDA). This trial evaluates the safety and efficacy, including effect on intact fibroblast growth factor 23 (iFGF23) of a high single dose and cumulative doses of iron isomaltoside in IBD patients with IDA. MATERIALS AND
methodsThe trial was a prospective, open-label, multi-centre trial conducted in IBD patients with IDA. Based upon haemoglobin (Hb) levels at baseline and weight, the patients received 1500, 2000, 2500 or 3000 mg of iron isomaltoside infused in single doses up to 2000 mg. The outcome measurements included adverse drug reactions (ADRs) and changes in haematology and biochemistry parameters.
resultsTwenty-one IBD patients with IDA were enrolled, receiving 1500 (seven patients), 2000 (eight patients), 2500 mg (four patients) or 3000 (two patients) mg of iron. No serious ADRs were observed. Four patients experienced nine mild to moderate ADRs (hypersensitivity, pyrexia, vomiting, constipation, abdominal pain, dyspepsia (two events) and eye allergy (two events)). In total, 15 (75%) patients had an increase in Hb of ≥2.0 g/dL during the trial, with normalisation of ferritin. No changes in iFGF23 or clinically significant hypophosphataemia were found.
conclusionRapid infusions of high-dose iron isomaltoside, administered as single doses up to 2000 mg and cumulative doses up to 3000 mg, were without safety concerns and were efficacious in increasing Hb levels in IBD patients. Iron isomaltoside did not induce profound phosphate wasting via increased iFGF23 levels.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.