A randomized controlled trial on optimal administration frequency of continuous erythropoietin receptor activator in hemodialysis patients with renal anemia.

JRCT ID: jRCTs031180030

Registered date:25/10/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: renal anemia
• Date of first enrollment: 20/02/2019
• Target sample size: 120
• Study type: Interventional
• Intervention(s): randomized

Outcome(s)

• Primary Outcome: The dose of epoetin beta pegol during 12 weeks of comparison period.

Secondary Outcome

(1)hepcidin
(2)ferittin and TSAT
(3)Ret-Hb and Ret-He
(4)Hb
(5)ERI
(6)the iron administration during comparison period.
(7) Presence of discontinuation of protocol treatment due to red blood cell transfusion or ESA type change after starting of comparison period

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Outpatients in maintenance hemodialysis with renal anemia
(2) Patients over 20 years of age
(3) Patients with a hemodialysis history of more than 12 weeks
(4) Patients with a history of receiving erythropoiesis stimulating agents for more than 12 weeks
(5) Patients who was obtained written informed consent regarding the participation of this study

Exclude criteria

(1)Heart failure above NYHA 3 degrees.
(2)Poorly controlled high blood pressure (diastolic blood pressure before dialysis 110 mmHg or more).
(3)Chemotherapy or radiotherapy for malignancy within 24 weeks.
(4)Red blood cell transfusion within 12 weeks.
(5)Major surgery within 12 weeks (thoracotomy, laparotomy etc.)
(6)Patients who are pregnant.
(7)Other patients judged inappropriate for the study
by doctors.

Related Information

• Primary Sponsor: Toya Yoshiyuki