Effectiveness of a Biosimilar Epoetin Alfa in Stable 'End Stage Renal Failure'
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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