A study on the procedure for treatment switch to epoetin beta pegol in the treatment of renal anemia in maintenance hemodialysis patients
- Conditions
- Renal Anemia Patients on Hemodialysis
- Registration Number
- JPRN-UMIN000008090
- Lead Sponsor
- Faculty of medicine, University of Miyazaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
Patients who have uncontrollable hypertension Patients with heart failure (NYHA functional class 3 or 4) Women who are pregnant, breastfeeding, or possibly pregnant. Patients who have known serious allergy or serious drug allergy (shock, anaphylactoid symptoms) Patients who have malignant tumor (including hematologic malignancy), severe infection, systemic hematologic disease (e.g. myelodysplastic syndrome, hemoglobinopathy), hemolytic anemia, or apparent hemorrhagic lesion such as gastrointestinal bleeding Patients who have received CERA before enrollment Patients whose AST or ALT level was100 IU/L or higher in the latest examination before enrollment Patients who received red blood cell transfusion within 16 weeks prior to enrollment Patients who are scheduled for surgery that may cause massive bleeding during the study period Patients who are judged ineligible by the investigator/sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects who maintain target Hb level after switching from Q2W to Q4W
- Secondary Outcome Measures
Name Time Method epoetin beta pegol dose, iron-related parameters