The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main Inclusion Criteria:
* Adult male and female patients w or w/o dialysis treatment
* Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve.
* Adequate iron substitution
Main Exclusion Criteria:
* History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies
* Contraindications for ESA therapy
* Serum albumin \< 3.0 g/dL
* Immunocompromized patients (immunosuppressive treatment, chemotherapy)
* Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection
* Systemic lupus erythematosus
* Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months
* History of malignancy of any organ system within the last 5 years
* History of use of any non-EU approved ESA