Clinical trial NCT02341547: Effectiveness of a Biosimilar Epoetin Alfa in Stable 'End Stage Renal Failure'
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Failure
Anaemia
Lead sponsor: Penang Hospital, Malaysia
Sponsor class: OTHER_GOV
First posted: 2015-01-19
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End Stage Renal Failure (ESRF) patients stable on Eprex who are switched over to Binocrit

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in haemoglobin levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Adverse drug reactions and serious adverse effects
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Penang Hospital
name: Ong Loke Meng, FRCS
role: PRINCIPAL_INVESTIGATOR
References: