A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient

Summary

This is an open-label, randomised, multicenter, Mircera-controlled, parallel-group, Phase III study to determine whether subcutaneous administered efepoetin alfa is as effective and well tolerated as subcutaneous Mircera for anaemia correction and maintenance in erythropoiesis stimulating agent (ESA)-naïve subjects who have CKD and are not on dialysis. ESA prior users who have stopped using ESA at least 12 weeks till screening will also be eligible for this study provided they fulfil all the subject entry criteria.

Timeline

Start

2020-07-02

Primary completion

2022-03-30

Completion

2023-06-30

Outcome

Met primary endpoint

release “Genexine’s long-acting anemia treatment GX-E4 phase 3 clinical trial interim result is presented at WCN2023, confirmed non-inferiority compared to Mircera” genexine.com ↗

Drugs

Indications