Efficacy and Safety of Subcutaneous Administration of Lyophilized Powder of Alpha-Erythropoietin to Maintains Hemoglobin Concentrations among Hemodialysis Patients
- Conditions
- Anemia associated with chronic kidney diseaseAnemiaHemodialysisLyophilised powderErythropoietin
- Registration Number
- TCTR20161214001
- Lead Sponsor
- Phramongkutklao hospital and College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 63
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method hemoglobin concentration 24 week g/d
- Secondary Outcome Measures
Name Time Method positive anti-EPO antibodies 24 week ELISA