Evaluation study of ferric carboxymaltose injection in hemodialysis patients

JRCT ID: jRCTs051230025

Registered date:23/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Iron deficiency anemia
• Date of first enrollment: 18/10/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Evaluation of efficacy and safety for 84 days after administration of ferric carboxymaltose to study subjects.

Outcome(s)

• Primary Outcome: Change in Hb level at 4 weeks after administration of FCM

Secondary Outcome

Change in hemoglobin (Hb) Level
Change in serum ferritin level
Change in Transferrin Saturation (TSAT)
Change in QOL values in EQ-5D-5L
Change in QOL value in SF-36

Key inclusion & exclusion criteria

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

Include criteria

1) Japanese patients who are 18 years of age or older at the time of informed consent
2) Maintained HD patients with HD history of 12 weeks or more who receive HD 3 times a week
3) Patients with iron deficiency anemia with Hb <10 g/dL and TSAT <20% or serum ferritin <100 ng/mL
4) Patients who are undergoing treatment for renal anemia with ESA or HIF-PH inhibitors and have not changed the dosage and administration since 4 weeks before the enrollment date
5) Patients who understand the contents of this study and can obtain written consent to participate in this study from themselves

Exclude criteria

1) Patients who fall under any of the following regarding blood transfusion
a.Those who received a blood transfusion within 8 weeks before the registration date
b.Those who are scheduled to undergo surgery requiring blood transfusion during the study period
2) Patients who are known or suspected to correspond to any of the following
a.Those with active bleeding such as gastrointestinal bleeding
b.Those with iron deficiency anemia due to blood loss other than HD
3) Patients with uncontrolled co-morbidities that may affect the safety of the study subject or the validity of the study results
4) Female patients who are pregnant or breastfeeding
5) Patients who are allergic to FCM
6) Patients weighing less than 25 kg (dry weight) within 1 month prior to enrollment
7) Patients who have had a malignancy within the past 5 years from the date of enrollment
8) Patients who have used study drug within 30 days prior to enrollment date
9) Patients who fall under any of the following regarding hospitalization
a. Those who are hospitalized at the time of registration
b. Those who are scheduled to be hospitalized during the study period
10) Patients with obvious pulmonary congestion on chest x-ray

Related Information

• Primary Sponsor: Araki Shin-ichi
• Source(s) of Monetary Support: Zeria Pharmaceutical Co., Ltd.