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

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

Study Overview

• Status: Unknown
• Conditions: End Stage Renal Failure; Anaemia
• Intervention / Treatment: Drug: a Biosimilar Epoetin Alfa

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

• Study Type: Observational
• Enrollment (Anticipated): 44

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

End Stage Renal Failure (ESRF) patients stable on Eprex who are switched over to Binocrit

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change in haemoglobin levels	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse drug reactions and serious adverse effects	It is a composite end point	12 weeks

Collaborators and Investigators

• Sponsor: Penang Hospital, Malaysia
• Investigators: Principal Investigator: Ong Loke Meng, FRCS, Penang Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 19, 2015

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 18, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency; Hematinics; Epoetin Alfa
• Other Study ID Numbers: CT14-HPP-003