Effectiveness of a Biosimilar Epoetin Alfa in Stable 'End Stage Renal Failure'

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, observational, non-inferior study in ESRF patients stable on Eprex who are switched to a Biosimilar Epoetin Alfa. Study plans to recrut 44 patients. Following recruitment, a baseline data collection of full routine laboratory test before switch to Binocrit.Primary endpoint is Mean change in haemoglobin levels at 12 weeks and Secondary endpoint is Mean change in haemoglobin levels at 6 weeks Safety endpoint will be Adverse drug reactions and serious adverse effects Analysis: Changes from baseline at Week 6 and Week 12 will be evaluated using paired t-test or Wilcoxon signed ranks test as appropriate. Changes in continuous variables over time were evaluated using repeated-measures analysis of variance. Patients with iron-deficiency (ferritin <100 ng/ml or transferrin saturation <20%) will be analysed separately

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Penang Hospital, Malaysia
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

1. End Stage Renal Failure (ESRF) patients on 3x per week HD for at least 6 months who are planned for conversion to Binocrit

2. Stable dose of Eprex and iron for at least 3 months

3. No active bleeding

Exclusion Criteria:

1. Allergy to erythropoietin

2. Bone marrow disorder

3. Acute/chronic bleeding

4. Acute illness requiring hospitalization within the last 3 months