Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
