Lead Sponsor

Amgen

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•≥ 18 years of age
•Diagnosis of chronic kidney disease with eGFR of 15-59 mL/min/1.73 m2 (MDRD equation)
•Two consecutive screening Hb values taken at least 7 days apart must each be \<10.0 g/dL
•TSAT ≥ 15%

•Upper or lower GI bleeding within 6 months before enrolment
•ESA use within 12 weeks before enrolment
•Uncontrolled hypertension
•Systemic haematologic disorders
•Prior history within 12 weeks before enrollment of events including: Acute myocardial ischemia, unstable angina, myocardial infarction, hospitalization for congestive heart failure, stroke or transient ischaemic attack, limb ischaemia, deep vein thrombosis, thromboembolism.
•Grand mal seizure within 6 months prior to enrolment
•Evidence of, or received chemotherapy or radiation therapy for, a malignancy within 5 years prior to enrolment.
•Red blood cell transfusion within 12 weeks prior to enrolment
•Androgen therapy within 8 weeks prior to enrolment
•Pregnancy or breast feeding, or inadequate contraception
•Currently receiving immunosuppressive therapy