Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients

Exclusion Criteria

• •Uncontrolled hypertension (defined as pre-dialysis diastolic blood pressure ≥ 100 mmHg or systolic blood pressure ≥180 mmHg);
• •Anemia secondary to other causes different to the CKD (e.g. multiple myeloma, aplastic anemia, leukemia;….)
• •Decompensated liver failure;
• •Clinical evidence of concurrent uncontrolled hyperparathyroidism (defined as serum parathyroid hormone (iPTH) \> 800 pg/ml);
• •Heart failure \[New York Heart Association (NYHA) class III and IV\];
• •Unstable angina pectoris, active cardiac disease, stroke and/or cardiac infarction within the last 6 months;
• •History of or active blood coagulation disorders including DVT, PTE, native access Thrombosis during last 6 months.
• •Thrombocytosis (platelet count \> 500,000/µl);
• •Thrombocytopenia (platelet count \< 100,000/µl);
• •White blood cell count \< 3,000/µl);
• •White blood cell count \>15,000/µl)
• •Recent Bleeding (acute or chronic bleeding within three months prior to screening);
• •Suspicion of or confirmed occult bleeding (increased reticulocyte count);
• •Clinical evidence of concurrent systemic infection, or inflammatory disease (e.g; diabetic foot, bed sore, access infection, CRP\> 30 mg/l,…)
• •Currently receiving treatment for epilepsy;
• •Major surgery within 3 months prior to randomization and during the conduct of the trial (except vascular access surgery);
• •Concomitant immunosuppressive therapy; patients on a short course of steroids (up to 7 days), topical or intranasal steroids are allowed in the study;
• •History of any malignant disease within the last 5 years (except excised non-melanoma skin cancer);
• •Women who are pregnant or breastfeeding;
• •Known history of severe drug-related allergies;
• •Known history of drug related allergy to Erythropoietin or one of the ingredients of the test or the reference products or hypersensitivity to mammalian-derived products;
• •Transplant received within one year prior to the start of the study;
• •Simultaneous participation in another clinical study or having received an Investigational Medicinal Product within three months before randomization in this study.
• •Psychiatric, addictive (drugs or alcohol) or any other disorder that compromises the ability to give an informed consent;
• •Any red blood cell transfusion during the last 3 months (measured at the time of eligibility verification);
• •Primary hematological disorder (e.g. myelodysplastic syndrome, myeloma, sickle cell anemia, hematological malignancy, multiple myeloma hemolytic anemia);
• •known resistance to the rHuEPO defined by a requirement \> 450 IU/kg/week by IV or 300 IU/kg/week by SC, equivalent to approximately 20.000 IU/week SC and in absence of iron deficiency;
• •who have suffered an event of active bleeding in the 30 days prior to the beginning of the study;
• •Morbid obesity, defined by a Body Mass Index (BMI) \> 37 kg/m2 in women and \> 40 kg/m2 in men.