Trial reportAmerican journal of hematology2019
A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial.
Trial report in American journal of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 49 papers, 4 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.
A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anemia (FERWON-IDA)
The Use of Preoperative Monoferric Infusion for Enhanced Recovery After Surgery-driven Elective Abdominal Surgery
Who cites it
49 citing papers in PubMed, 4 syntheses or guidelines pooled it, 102 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
- A systematic literature review and meta-analysis of the incidence of serious or severe hypersensitivity reactions after administration of ferric derisomaltose or ferric carboxymaltose.International journal of clinical pharmacy · 2023Pooled it
- Guideline
- 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
- Efficacy of Single-Dose Intravenous Ferric Derisomaltose for Iron Deficiency Anemia in Pregnancy.American journal of hematology · 2026Trial
- [Comparison of the efficacy and safety between high-dose intravenous iron and oral iron in treating iron deficiency anemia: a multicenter, prospective, open-label, randomized controlled study].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2024Trial
- Trial
- Intravenous ferric derisomaltose versus saccharated ferric oxide for iron deficiency anemia associated with menorrhagia: a randomized, open-label, active-controlled, noninferiority study.International journal of hematology · 2022Trial
- Trial
- Safety of ferric derisomaltose and iron sucrose in patients with iron deficiency anemia: The FERWON-IDA/NEPHRO trials.American journal of hematology · 2021Trial
- 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
- Comment on Inghilleri, G.; Franchini, M. Hypophosphatemia in Patients Receiving Intravenous Iron Supplementation for Iron-Deficiency Anemia: A Narrative Review.Journal of clinical medicine · 2026Article
- Article
- Article
- Ferric Derisomaltose Compared to Iron Sucrose in Iron Deficiency Anemia: A Meta-Analysis of Randomized Controlled Trials.Journal of clinical medicine · 2026Article
- Attitudes towards ferric derisomaltose among Swiss patients with iron deficiency and their treating physicians: the prospective, observational Real-CHOICE study.Archives of gynecology and obstetrics · 2025Observational
- Real-world evaluation of an intravenous iron service for the treatment of iron deficiency with or without anemia.Scientific reports · 2025Article
- Understanding and Managing Infusion Reactions and Hypophosphataemia With Intravenous Iron-A Nurses' Consensus Paper.Nursing open · 2025Article
- Effect of Ferric Derisomaltose on Fatigue in Iron Deficiency Anemia Associated With Abnormal Uterine Bleeding.American journal of hematology · 2025Article
- No longer to be ignored: Hypophosphatemia following intravenous iron administration.Reviews in endocrine & metabolic disorders · 2025Review
Corrections and comments
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Authors and funding
6 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Iron deficiency anemia (IDA) is prevalent, and intravenous iron, especially if given in a single dose, may result in better adherence compared with oral iron. The present trial (FERWON-IDA) is part of the FERWON program with iron isomaltoside 1000/ferric derisomaltose (IIM), evaluating safety and efficacy of high dose IIM in IDA patients of mixed etiologies. This was a randomized, open-label, comparative, multi-center trial conducted in the USA. The IDA patients were randomized 2:1 to a single dose of 1000 mg IIM, or iron sucrose (IS) administered as 200 mg intravenous injections, up to five times. The co-primary endpoints were adjudicated serious or severe hypersensitivity reactions, and change in hemoglobin from baseline to week eight. A total of 1512 patients were enrolled. The frequency of patients with serious or severe hypersensitivity reactions was 0.3% (95% confidence interval: 0.06;0.88) vs 0.4% (0.05;1.45) in the IIM and IS group, respectively. The co-primary safety objective was met, and no risk difference was observed between groups. The co-primary efficacy endpoint of non-inferiority in hemoglobin change was met, and IIM led to a significantly more rapid hematological response in the first two weeks. The frequency of cardiovascular events was 0.8% and 1.2% in the IIM and IS group, respectively (P = .570). The frequency of hypophosphatemia was low in both groups. Iron isomaltoside administered as 1000 mg resulted in a more rapid and more pronounced hematological response, compared with IS, which required multiple visits. The safety profile was similar with a low frequency of hypersensitivity reactions and cardiovascular events.
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Registered trials
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.