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

NCT02341547 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2015-01-21

No results posted yet for this study

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

Conditions

  • End Stage Renal Failure
  • Anaemia

Interventions

DRUG

a Biosimilar Epoetin Alfa

End Stage Renal Failure patients stable on Eprex switched to Binocrit

Sponsors & Collaborators

  • Penang Hospital, Malaysia

    lead OTHER_GOV

Principal Investigators

  • Ong Loke Meng, FRCS · Penang Hospital

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-11-30
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02341547 on ClinicalTrials.gov