Hemodialysis Anemia Hemodialysis Anemia Erythropoietin
Conditions
Interventions
lyophilized power of EPO alpha (treatment group),standard reference EPO alpha biological product (control group)
Active Comparator Drug,Placebo Comparator Drug
Sponsors
Phramongkutklao Hospital and College of Medicine
Berli Jucker Public Co. Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: age, 18 years or older, treatment with hemodialysis for at least three months, and a single pool Kt/Vurea of 1.2 or greater per dialysis treatment, adequate iron status (≥20% of transferrin saturation and ≥100 ng/mL of ferritin) and stable hemoglobin level of 10-12 g/dL with standard reference EPO alpha biological product (EPREX®) treatment at least 3 months.
Exclusion criteria
Exclusion criteria: patients with identify causes of anemia such as gastrointestinal hemorrhage, hematologic malignancy, chronic infection, and malnutritonal anemia, active malignancy, pregnancy, severe hyperparathyroidism indicated by a serum parathyroid hormone level >9x ULN, uncontrolled hypertension (mean systolic blood pressure > 180 or diastolic blood pressure > 110 mmHg), active epilepsy or seizure within 8 weeks before screening, and active infection or hospitalization within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin 12 weeks g/dL | — |
Secondary
| Measure | Time frame |
|---|---|
| erythropoitin dose 12 weeks unit/kg/week | — |
Countries
Thailand
Contacts
Public ContactBancha Satirapoj
Phramongkutklao Hospital and College of Medicine
Outcome results
None listed