NCT02341547

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

A Prospective, Observational, Non-inferiority Study to Assess the Effectiveness of a Biosimilar Epoetin Alfa in Maintaining Haemoglobin Levels in Stable 'End Stage Renal Failure' Patients on Haemodialysis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 44 (estimated)
• Sponsor: Penang Hospital, Malaysia · Other Government
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• End Stage Renal Failure
• Anaemia

Interventions

Type	Name	Description
DRUG	a Biosimilar Epoetin Alfa	End Stage Renal Failure patients stable on Eprex switched to Binocrit

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-01-19
• Last updated: 2015-01-21