Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

Summary

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.

Timeline

Start

2015-12

Primary completion

2021-10-09

Completion

2021-10-09

Publications

• Miao B, Isachkina AN, Shutov EV, Selyutin AA, Kvitkova LV, Shilo VY, Vetchinnikova ON, Alexandrov IV, Perlin DV, Zuev AV, Davydkin IL, Mironova TP, Solovyova OM, Tutin AP, Omelchenko AM, Vareesangthip K, Khadikova NG, Li M, Li X. Biosimilar erythropoietin in anemia treatment (BEAT)-Efficacy and safety of a 1:1 dose conversion from EPREX(R) to EPIAO(R) in patients with end-stage renal disease on hemodialysis: A prospective, randomized, double blind, parallel group study. Medicine (Baltimore). 2022 Nov 25;101(47):e31426. doi: 10.1097/MD.0000000000031426.

Drugs

Indications