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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age should be greater than or equal to the minimum age of consent in the applicable country
✓. Stage 3 or 4 CKD (eGFR ≥ 15 and \< 60 mL/min/1.73 m2)
✓. ESA-naive (no prior ESA use) subjects whose Hb at baseline is ≥ 8 g/dL and \< 10 g/dL, or ESA prior users whose Hb at baseline is ≥ 8 g/dL and \< 10 g/dL and who have stopped using ESA at least 12 weeks till the screening
✓. Subject must be willing to complete all study-related activities and follow-up visits
✓. Evidence of a signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion criteria
✕. Need for dialysis therapy expected in the next 12 months or rapid progression of CKD (e.g., eGFR decrease of \>20% within 12 weeks)
✕. Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to screening, or blood transfusion is anticipated during the study period
✕. Have a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of ≥ 1 g/dL, within the last 8 weeks prior to screening
✕. Have an unstable Hb for any reason, in the investigator's opinion
✕. Have non-renal anaemia (any anaemia where the investigator considers the anaemia is predominantly due to a non-renal cause. Non-renal causes include, but are not limited to vitamin B12 or folic acid deficiency, homozygous sickle-cell disease, thalassemia of all types, other non-renal cause of anaemia such as myelodysplasia or haematological malignancies)
What they're measuring
1
To assess the efficacy of efepoetin alfa in the treatment of anaemia associated with CKD as measured by haemoglobin (Hb) response rate at the end of correction treatment evaluation period
Timeframe: Measurement from the date of Randomization till the End of the Corrective Treatment period, assessed up to 20 weeks.