Trial reportInternational journal of hematology2019
Safety and efficacy of intravenous ferric carboxymaltose in Japanese patients with iron-deficiency anemia caused by digestive diseases: an open-label, single-arm study.
Trial report in International journal of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.
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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.
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Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 17 citations in OpenAlex.
- Risk of Infection Associated With Administration of Intravenous Iron: A Systematic Review and Meta-analysis.JAMA network open · 2021Pooled 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
- Comparison of Diagnosis Accuracy between a Backpropagation Artificial Neural Network Model and Linear Regression in Digestive Disease Patients: an Empirical Research.Computational and mathematical methods in medicine · 2021Pooled it
- Hypophosphataemia following iron infusion: a narrative review of an increasingly recognised complication.Internal medicine journal · 2026Review
- Osteomalacia Following Iron Infusion Therapy in a Patient With Rendu-Osler-Weber Syndrome: F-18-FDG PET/CT Discrimination of a Stress Fracture in the Setting of a Musculoskeletal Tumor Mimic.Clinical case reports · 2026Article
- Prevalence, predictors, and natural history of hypophosphatemia following iron infusion.JBMR plus · 2025Article
- Intravenous ferric derisomaltose for iron-deficiency anemia associated with gastrointestinal diseases: a single-arm, randomized, uncontrolled, open-label study.International journal of hematology · 2022Article
- Hypophosphataemia, fibroblast growth factor 23 and third-generation intravenous iron compounds: a narrative review.Drugs in context · 2021Review
- Severe osteomalacia with multiple insufficiency fractures secondary to intravenous iron therapy in a patient with Rendu-Osler-Weber syndrome.Bone reports · 2020Article
- Hypophosphatemia Associated with Intravenous Iron Therapies for Iron Deficiency Anemia: A Systematic Literature Review.Therapeutics and clinical risk management · 2020Review
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Iron-deficiency anemia (IDA) accounts for majority of anemia. Although iron replacement therapy is effective, in Japan, conventional iron formulations have disadvantages such as gastrointestinal side effects for oral formulations and issues of frequent administration for intravenous (IV) formulations. Ferric carboxymaltose (FCM), which overcomes these limitations, is widely used as an IV iron source overseas. In this multi-center, open-label, single-arm study, we investigated the safety and efficacy of FCM up to 12 weeks after the start of administration in patients with IDA caused by digestive diseases. Thirty-nine patients diagnosed with IDA based on hemoglobin and serum ferritin levels were included. Eligible subjects were administered FCM until the total calculated iron dose (1000 or 1500 mg) was achieved over intervals of at least 1 week. A single iron dose was 500 mg. In the full analysis set (n = 39), the incidence of adverse events and adverse drug reactions was 71.8 and 48.7%, respectively. All events were as expected from the safety profile of IV iron. The mean change from baseline (10.39 g/dL) to the highest observed hemoglobin level was 3.31 g/dL. These results indicate the safety and efficacy of FCM for treating IDA caused by digestive diseases in Japanese patients.
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