Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sandoz
This is a randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of HX575 epoetin alfa vs. US-licensed epoetin alfa (Epogen®/Procrit®) in the treatment of anemia associated with chronic kidney disease (CKD).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous maintenance therapy with Epogen® or Procrit® at least once per week
Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period
Adequate iron substitution
You may not be if
Contraindications for Erythropoiesis Stimulating Agent (ESA) therapy
History of Pure Red Cell Aplasia (PRCA), or anti-erythropoietin (EPO) antibodies
Known Human Immunodeficiency Virus (HIV) or Hepatitis B infection
Hepatitis C infection on an active treatment
Symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III and IV)
Unstable angina pectoris, or cardiac infarction during the last 6 months prior to randomization
Percutaneous coronary intervention, or coronary artery bypass grafting during the last 6 months prior to randomization
History of malignancy of any organ system
Systemic lupus erythematous
Immunocompromized patients
Clareo Health | Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
