Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)

Inclusion Criteria

• •Male and female CKD subjects with or without dialysis treatment
• •Age \> 18 years
• •Subjects under documented stable maintenance therapy with ESA, s.c. at least once per week and in accordance with the relevant SmPC, for at least 3 months with a total weekly dose of ≤ 300 IU/kg/week
• •Subjects with controlled symptomatic anemia, defined as mean Hb level between 10.0 g/dL and 12.0 g/dL, based on four Hb measurements during the four-week baseline period
• •Adequate iron status, serum ferritin ≥ 100 µg/L or transferrin saturation ≥ 20%
• •Confirmed negative anti-EPO antibody assay from sample taken at screening visit -4