A single-arm study to evaluate the efficacy and safety of a single dose of ferric carboxymaltose injection (Feinject intravenous injection 500 mg) in hemodialysis patients with iron deficiency anemia - FCM HD Trial

Araki Shin-ichi0 个研究点目标入组 30 人开始时间: 2023年5月23日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•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

•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

发起方

Araki Shin-ichi