Efficacy and Safety Study of GerEPO

Summary

The purpose of the study is to establish the equivalence of GerEpo with the standard treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect to hemoglobin response and to establish the longer-term safety profile of GerEpo, with special regards for the occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity related adverse event

Timeline

Start

2005-04

Primary completion

—

Completion

2005-11

Outcome

Met primary endpoint

paper The 95% confidence interval was -0.42 to 0.46, which lies within the margin of equivalence (+/-0.5 g/dL). PMID 17803464 ↗

Publications

• Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
• Goh BL, Ong LM, Sivanandam S, Lim TO, Morad Z; Biogeneric EPO Study Group. Randomized trial on the therapeutic equivalence between Eprex and GerEPO in patients on haemodialysis. Nephrology (Carlton). 2007 Oct;12(5):431-6. doi: 10.1111/j.1440-1797.2007.00831.x.

Drugs

Indications