Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934 (DIALOGUE 2)

Inclusion Criteria:

• Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening
• Estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease or the formula according to Matsuo, et al.)
• Not on dialysis and not expected to begin dialysis during the treatment period of the study (at least 16 weeks from randomization)
• Treated with darbepoetin via intravenous (IV) or subcutaneous (SC) route with a weekly, bi-weekly, or monthly dose, having had no more than one dose change within 8 weeks prior to randomization
• At least one kidney
• Mean screening hemoglobin (Hb) concentration of 10.0 to 12.0 g/dL
• Men who agree to use adequate contraception when sexually active or women without childbearing potential

Exclusion Criteria:

• Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
• Active hemolysis or diagnosis of hemolytic syndrome
• History of myelodysplastic syndrome, multiple myeloma, marrow fibrosis, or pure red-cell aplasia (PRCA)
• History of hemosiderosis or hemochromatosis
• Hereditary hemoglobinopathies (such as sickle cell disease and thalassemia major)
• Aplastic anemia
• Chronic lymphoproliferative diseases
• Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy that is likely to require invasive treatment (intraocular injections or laser photocoagulation) during the study
• Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
• Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
• Uncontrolled and symptomatic hyperparathyroidism
• Uncontrolled active infection
• Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively treated > 3 years prior to randomization
• Any allograft (including renal allograft) in place and on immunosuppressive therapy or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject)