Last updated on May 2018

Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)


Brief description of study

This study is aimed to comprehensively establish the bio-similarity/bioequivalence in EPIAO and EPREX in terms of 52-week comparisons in efficacy, safety and immunogenicity. The targeted population is anaemia patients with end-stage chronic renal disease who previously received epoetin treatment and on haemodialysis.

Detailed Study Description

This is a prospective, randomized, double blind, parallel group two arm study to establish the therapeutic equivalence, safety and tolerability of EPIAO as compared to EPREX in the treatment of CKD related anaemia in subjects who are on haemodialysis. A total of 264 subjects will be randomized into two groups in a 1:1 ratio. Treatment arm A will receive EPIAO 1-3 times a week, intravenously for period of 52 weeks and treatment arm B will receive EPREX, 1-3 times a week, intravenously for period of 52 weeks.

Clinical Study Identifier: NCT02947438

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