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)

JRCT ID: jRCTs031210634

Registered date:01/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Iron-Deficiency Anemia
• Date of first enrollment: 01/03/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Switching from previous oral iron preparation to ferric citrate hydrate, RIONA

Outcome(s)

• Primary Outcome: Completion rate of medication during the study period

Secondary Outcome

(1)Medication compliance
(2)Completion rate of medication during the study period in each previous oral iron preparation
(3)Completion rate of medication from Visit 4 to the day before Visit 5
(4)Red blood cell-related parameters
(5)Iron-related parameters
(6)Incidence of adverse events and adverse reactions
(7)Patients satisfaction with ferric citrate hydrate
(evaluation of treatment with ferric citrate hydrate : degree of nausea and vomiting, degree of interference with daily life)
(8)Overall evaluation of the treatment with ferric citrate hydrate
(9)QoL index (EQ-5D-5L and SF-36v2 scores)
(10)Labor productivity (mWPAI:GH scores)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include 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 medication"confirms 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

Exclude 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

Related Information

• Primary Sponsor: Osuga Yutaka
• Secondary Sponsor: Torii Pharmaceutical Co.,Ltd