This clinical trial is focused on studying the treatment of anemia in patients with chronic kidney disease who are on dialysis. Anemia is a condition where the body does not have enough healthy red blood cells to carry adequate oxygen to the body’s tissues, often leading to fatigue and weakness. Chronic kidney disease is a long-term condition where the kidneys do not work as well as they should. Dialysis is a treatment that takes over the job of the kidneys when they fail. The study will compare the effectiveness and safety of a new medication called efepoetin alfa (also known by the code name GX-E4) with an existing medication called darbepoetin alfa, which is marketed under the name Aranesp. Both medications are solutions for injection and are used to help increase red blood cell production in the body.

The purpose of the study is to evaluate how well efepoetin alfa controls hemoglobin levels compared to darbepoetin alfa in patients undergoing hemodialysis. Hemoglobin is a protein in red blood cells that carries oxygen throughout the body. The study will involve participants receiving either efepoetin alfa or darbepoetin alfa through intravenous injections over a period of up to 52 weeks. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study aims to determine if efepoetin alfa is not inferior to darbepoetin alfa in maintaining stable hemoglobin levels in these patients.

Throughout the study, participants will have their hemoglobin levels monitored regularly to assess the effectiveness of the treatment. The study will also observe any side effects or safety concerns associated with the medications. By the end of the study, researchers hope to gather enough information to understand whether efepoetin alfa is a viable alternative to darbepoetin alfa for treating anemia in patients with chronic kidney disease on dialysis.