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
Women without childbearing potential
Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening
Estimated glomerular filtration rate of \< 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease \[MDRD\] 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)
Not treated with any erythropoiesis-stimulating agent (ESA) within 8 weeks before randomization
Mean screening Hb concentration \</= 10.5 g/dL
Body weight of 45 kg to 125 kg, inclusive, at screening
You may not be if
Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
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
Subjects treated with any ESA within the 8 weeks before randomization
Red blood cell (RBC) containing transfusion within the 8 weeks before randomization
History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from initial screening visit
Severe rhythm or conduction disorders (e.g., HR \< 50 or \> 110 bpm, atrial flutter, prolonged QT \> 500 msec, third degree atrioventricular \[AV\] block)
New York Heart Association Class III or IV congestive heart failure
Severe hepatic insufficiency (defined as alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 3 x the upper limit of normal \[ULN\], total bilirubin \> 2 mg/dL, or Child-Pugh B and C) or active hepatitis, in the investigator's opinion
