Effectiveness of a Biosimilar Epoetin Alfa in Stable 'End Stage Renal Failure'
Effectiveness of a Biosimilar Epoetin Alfa in Stable 'End Stage Renal Failure'
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
Anaemia in CKD is associated with reduced quality of life and increased cardiovascular
 disease, hospitalizations, cognitive impairment, and mortality. Correcting anaemia is
 considered an important part of slowing or even stopping the progression of CKD. Recombinant
 human erythropoietins (EPO) such as epoetin alfa are erythropoiesis-stimulating agents (ESAs)
 that are important treatment options. The ESA that is currently used in the hospital is
 Eprex®, a recombinant human EPO epoetin alfa which will soon be replaced by Binocrit®, a
 biosimilar ESA approved by the European Medicines Agency (EMA). We want to see whether
 maintenance of haemoglobin in stable ESRF patients would be affected by this switch in real
 life practice in the Malaysian population.

 This is a prospective, observational, non-inferiority study in ESRF patients stable on Eprex
 who are switched to a Bio similar Epoetin Alfa .

 Study population will be 44 End stage renal failure patients from Penang and Seberang Jaya
 hospital.Following recruitment, a baseline data collection of full routine laboratory test
 before switch to a Bio similar Epoetin Alfa .Primary endpoint is Mean change in haemoglobin
 levels at 6 weeks and Secondary endpoint is Mean change in haemoglobin levels at 12 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
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