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

Anaemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02341547
• Other study ID #: CT14-HPP-003
• Status: Not yet recruiting
• Phase: N/A
• First received: January 13, 2015
• Last updated: January 18, 2015
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Penang Hospital, Malaysia
• Contact: Ong Loke Meng, FRCS
• Phone: 00 604 2225333
• Email: onglm[@]crc.gov.my
• Is FDA regulated: No
• Health authority: Malaysia: National Medical Research Register
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anaemia
• End Stage Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• a Biosimilar Epoetin Alfa
End Stage Renal Failure patients stable on Eprex switched to Binocrit

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Penang Hospital, Malaysia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in haemoglobin levels		12 weeks	No
Secondary	Adverse drug reactions and serious adverse effects	It is a composite end point	12 weeks	Yes