A multicenter switching study to ferric citrate hydrate for treatment of iron deficiency anemia in patients with intolerance to previous oral iron preparation (RIO-SWITCH)

Osuga Yutaka0 个研究点目标入组 30 人开始时间: 2022年3月1日最近更新: 2024年1月22日

适应症

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•1)Patients who can submit written informed consent of their own will.
•2)Female patients aged 18 years or older at the time of providing written informed consent.
•3)Patients who took oral iron preparations a) (excluding OTC drugs) for the treatment of IDA prior to the date of providing written informed consent, and who are assessed as intolerant of those medications due to adverse reactions such as nausea and/or vomiting by investigator using questionnaire b)
•a)sodium ferrous citrate, ferrous fumarate, dried ferrous sulfate and ferric pyrophosphate, soluble
•b)Questionnaire on the current anemia medicationconfirms the patient's intention to stop taking the oral iron medication or to switch to another medication, and that the reason is due to nausea and/or vomiting.
•4) Patients who meet the criteria of Hb values level less than 11.0 g/dL at the time of eligibility confirmation.
•5)Patients who can respond to electronic patient-reported outcome

•1) Patients with a history of hypersensitivity
•to the components of this drug
•2) Patients with gastrointestinal disorders
•such as peptic ulcer and inflammatory bowel disease
•3) Patients with paroxysmal nocturnal
•hemoglobinuria
•4) Patients with hepatitis, such as chronic
•hepatitis C
•5) Patients who are pregnant or breastfeeding
•6) Patients who have taken ferric citrate hydrate as RIONA tablets before
•7) Patients with nausea and/or vomiting caused by drugs other than oral iron preparations
•8) Patients who are participating in other clinical studies or trials with interventions
•9) Patients who are judged by the investigator to be unsuitable for the study

发起方

Osuga Yutaka