Renal Anemia Patients on Hemodialysis
Conditions
Interventions
Switch from the EPO of pre-medical treatment to the epoetin beta pegol by medication once for every two weeks, and switch into medication once for every four weeks after two months.
Switch from the E
Sponsors
Faculty of medicine, University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who are on hemodialysis for a prescribed period (at least 6 months) and receiving rHuEPO preparation for renal anemia for at least 3 months
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who maintain target Hb level after switching from Q2W to Q4W | — |
Secondary
| Measure | Time frame |
|---|---|
| epoetin beta pegol dose, iron-related parameters | — |
Countries
Japan
Contacts
Public ContactTATSUNORI TOIDA
University of Miyazaki Faculty of medicine
Outcome results
None listed