Comparative Efficacy and Safety Study between Lyophilized power of Alpha-Erythropoietin and Alpha-Erythropoietin Reference Product for Hemoglobin Maintenance in Patients with Hemodialysis

Phase 4

Completed

• Conditions: HemodialysisAnemia; Hemodialysis; Anemia; Erythropoietin

• Registration Number: TCTR20140212001
• Lead Sponsor: Phramongkutklao Hospital and College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-02-01
• Study Start: 2014-02-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemoglobin 12 weeks g/d

Secondary Outcome Measures

Name	Time	Method
erythropoitin dose 12 weeks unit/kg/week