Research for correlation between ESA resistance and serum hepcidin concentration

JRCT ID: jRCT1031230345

Registered date:13/09/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Anemia with CKD
• Date of first enrollment: 08/09/2023
• Target sample size: 60
• Study type: Observational

Outcome(s)

• Primary Outcome: Correlation between ERI and serum hepcidin concentration
• Secondary Outcome: Research the correlation between subject background or various laboratory tests and serum hepcidin concentrations

Key inclusion & exclusion criteria

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

Include criteria

(1) Patients aged 18 years or older at the time of informed consent
(2) Patients receiving hemodialysis (including hemodiafiltration) 3 times a week for at least 12 weeks prior to informed consent
(3) Patients receiving ESA treatment for at least 8 weeks prior to informed consent, and whose latest ESA treatment interval is within 4 weeks
(4) Patients who have been administered the same type of ESA for at least 8 weeks prior to informed consent, and the administration interval and dose of the last two times are same (Epogin, Espo, and Epoetin Alfa Biosimilar are considered the same type of ESA)
(5) Patients who are assessed to have no health problems for the participation in this study by principal investigator or co-investigators

Exclude criteria

(1) Patients with severe complications such as cerebral, hepatic, renal, cardiac, pulmonary, gastrointestinal, hematological, endocrine, metabolic or psychiatric disease
(2) Those who have participated in other clinical trials involving medical devices or clinical research involving interventions within 12 weeks prior to this study
(3) Patients judged to be unsuitable as research subjects by principal investigator or co-investigators

Related Information

• Primary Sponsor: Mitobe Yuko