Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sandoz
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Systemic cyclosporine
History of PRCA or aplastic anemia
History of anti-EPO antibodies
Uncontrolled hypertension
Clareo Health | Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)
