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

Not Applicable
Conditions
renal anemia
Registration Number
JPRN-jRCTs031180030
Lead Sponsor
Toya Yoshiyuki
Brief Summary

In hemodialysis patients, we did not find significant difference in CERA dosage, Hb maintenance and iron metabolism in QW group compared with Q2W group.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
120
Inclusion 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

Exclusion 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The dose of epoetin beta pegol during 12 weeks of comparison period.
Secondary Outcome Measures
NameTimeMethod
(1)hepcidin<br>(2)ferittin and TSAT<br>(3)Ret-Hb and Ret-He<br>(4)Hb<br>(5)ERI<br>(6)the iron administration during comparison period.<br>(7) Presence of discontinuation of protocol treatment due to red blood cell transfusion or ESA type change after starting of comparison period
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