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)

Not Applicable

• Conditions: Iron-Deficiency Anemia

• Registration Number: JPRN-jRCTs031210634
• Lead Sponsor: Osuga Yutaka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified