Biosimilar Erythropoietin in Anaemia Treatment (Maintenance Phase Study)

Phase 3 Completed 207 enrolled Shenyang Sunshine Pharmaceutical Co., LTD. Navitas Life Sciences GmbH · collab

RandomizedParallel-groupQuadruple-blindTreatment

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

Outcome

Met primary endpoint

paper The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ±0.5 g/dL. PMID 36451454 ↗

paper The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ± 45 IU/kg. PMID 36451454 ↗

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

Evaluation	Drug	Modality	Dose	Route
Comparator	Eprex	Unknown	2000 iu	Intravenous
Comparator	Eprex	Unknown	3000 iu	Intravenous
Comparator	Eprex	Unknown	4000 iu	Intravenous
Subject	epoetin alfa	Protein / enzyme biologic	2000 iu	Intravenous
Subject	epoetin alfa	Protein / enzyme biologic	3000 iu	Intravenous
Subject	epoetin alfa	Protein / enzyme biologic	4000 iu	Intravenous