TCTR20161214001
Completed
Phase 4
Efficacy and Safety of Subcutaneous Administration of Lyophilized Powder of Alpha-Erythropoietin to Maintains Hemoglobin Concentrations among Hemodialysis Patients
Phramongkutklao hospital and College of Medicine0 sites63 target enrollmentDecember 14, 2016
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Anemia associated with chronic kidney disease
- Sponsor
- Phramongkutklao hospital and College of Medicine
- Enrollment
- 63
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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