drugset / Trial / NCT04155125

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

NCT04155125

RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Efepoetin Alfa Protein / enzyme biologic 4 ug/kg Subcutaneous
Comparator methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 0.6 ug/kg Subcutaneous