To Evaluate the Efficacy, Safety, and Immunogenicity of Subcutaneous Eporon Versus Epoetin Alfa (Eprex)

• Status: Recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate 24-week efficacy and 52 week immunogenicity of subcutaneous Eporon versus Epoetin Alfa (Eprex) in the treatment of anemia associated with chronic renal failure in pre-dialysis patients. A total of 214 patients will be enrolled in Turkey.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Glomerular Filtration Rate <60 mL/min/1.73m2 (estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)

• Hemoglobin (Hb) level in the range of ≥7 g/dL and <10 g/dL at screening

• Erythropoiesis Stimulating Agent (ESA) naïve subjects or previously treated subjects with ESA-free period of >3 months (in case of pre-treatment with long-acting ESA such as pegylated epoetin, the long-acting ESA-free period of >6 months)

Exclusion Criteria:

• Subjects who have received steady dialysis or subjects who are currently on dialysis

• Subjects who have rapid progression of chronic renal failure (as per investigators' discretion; e.g., a GFR decrease of >20% within 12 weeks prior to screening)

• Subjects who have already undergone renal transplantation or who are scheduled for renal transplantation