Anemia associated with chronic kidney disease Anemia Hemodialysis Lyophilised powder Erythropoietin
Conditions
Interventions
The active ingredient in HEMAX is lyophilized powder of EPO alpha,
a 165-
acid glycoprotein produced by recombinant DNA technology in genetically modified mammal cells. Its molecular weight is 30.4 KDa and its amino acid structure is identical to that of natural erythropoie
acid glycoprotein produced by recombinant DNA technology.
Experimental Drug,Active Comparator Drug
lyophilized powder EPO alpha ,standard liquid EPO alpha
Sponsors
Phramongkutklao hospital and College of Medicine
Berli Jucker Public Company Limited,
Bangkok,
Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Eligibility included male and female patients aged 18 to 85 years diagnosed with CKD receiving hemodialysis who presented stable hemoglobin levels of 10-11.5 g/dL with standard liquid EPO alpha product (EPREX, CILAG AG, Switzerland) treatment at least 12 weeks. All patients had adequate dialysis by a single pool Kt/Vurea greater than 1.2 per dialysis treatment and adequate iron status (≥20% of transferrin saturation and ≥200 ng/mL of ferritin).
Exclusion criteria
Exclusion criteria: Patients were excluded from the study if they were on peritoneal dialysis or had identified causes of anemia such as gastrointestinal hemorrhage, hematologic malignancy, chronic infection and nutritional anemia. In addition, patients were excluded if they were hyporesponsive to EPO (defined as an intravenous EPO dose of >360 IU/kg weekly or an intravenous darbepoetin dose of >1.8 mg/kg weekly) within the prior 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hemoglobin concentration 24 week g/dL | — |
Secondary
| Measure | Time frame |
|---|---|
| positive anti-EPO antibodies 24 week ELISA | — |
Countries
Thailand
Contacts
Public ContactBancha Satirapoj
Phramongkutklao hospital
Outcome results
None listed