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

About this trial

Last updated 6 years ago

Study ID

DAEPO_ANE_III

Status

Unknown

Type

Interventional

Phase

Phase 3

Placebo

Accepting

19 to 74 Years

All Sexes

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the participation requirements?

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