Renal anemia on hemodialysis
Conditions
Interventions
(randomized study part) Active group: Patients take epoetin beta pegol with the target hemoglobin level of 11 g/dL or more. Maintenance group: Patients take epoetin beta pegol to maintain their he
Sponsors
EP CRSU Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (randomized study part) 1. Between 20 and 85 years of age (inclusive) at the time of giving informed consent 2. Receiving drug therapy with ESA other 3.More than one year after dialysis induction 4. A poor ESA responder,defined as no improvement in anemia after six months'treatment with an ESA. 5. Is not iron deficient. 6. Has personally consented in writing to participate in the randomized part of the study. (observational study part) 1. 20 years of age or older at the time of giving informed consent 2. Receiving treatment for renal anemia with an ESA other than epoetin beta pegol and is scheduled to be switched to epoetin beta pegol. 3. Has been on hemodialysis for at least one year. 4. Has personally consented in writing to participate in the study.
Exclusion criteria
Exclusion criteria: (randomized study part) (1) Anemia for other reasons than the renal anemia:Complication of apparent hemorrhagic lesion, hematologic disease (e.g. leukemia, malignant lymphoma, myelodysplastic syndrome, aplastic anemia), or apparent chronic inflammation (e.g. rheumatoid arthritis, inflammatory bowel disease) (2) Hypersensitivity to epoetin beta pegol, erythropoietin, or darbepoetin alfa (3) Complication of malignant tumor (4) Pregnancy, nursing or planning to become pregnant during the study (women only) (5) Judged as ineligible to the randomized study in the opinion of the investigator (observational study part) 1.Hypersensitivity to epoetin beta pegol, erythropoietin, or darbepoetin alfa 2.Pregnancy, nursing or planning to become pregnant during the study (women only) 3.Judged as ineligible to the randomized study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular prognosis(randomized study part) Time to cardiovascular events such as cardiac death (death with heart failure, lethal myocardial infarction, sudden cardiac death), heart failure requiring hospitalization, and acute coronary syndrome (nonfatal myocardial infarction, unstable angina) requiring hospitalization. (observational study part) Cardiovascular events a. Relationship with ERI b. Relationship with iron | — |
Secondary
| Measure | Time frame |
|---|---|
| (randomized study part) (1) Cardiovascular events (2) Death (3) Relationship between iron index and prognosis (4) Quality of life (5) Safety (observational study part) (1)Cerebrovascular events, composite events and total deaths a. Relationship with ERI b. Relationship with iron indices (2)Relationship between hemoglobin and cardiovascular events and cerebrovascular events (3)Safety | — |
Countries
Japan
Contacts
Public ContactKatsuhiko Omote
EP CRSU Co., Ltd. Clinical Research Promotion Dept.
Outcome results
None listed