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

This is an interventional treatment trial for Anemia in End-Stage Renal Disease focused on measuring End-Stage Renal Disease, Anemia, Erythropoietin, Hemoglobin Read More

Inclusion Criteria:

• Aged between 18 and 70
• ESRD patients who are on hemodialysis for ≥3 months.
• Hb level 8- 11.5 g/dl
• Patients are on adequate hemodialysis: the minimally adequate dose of hemodialysis given 3 times per week should be a spKt/V (single-pool delivered Kt/V; clearance of urea x dialysis time/volume of distribution) of 1.2 per dialysis. For treatment periods of less than 5 hours, an alternative minimum dose is a urea reduction rate (URR) of 65%. All types of hemodialysis systems and hemodiafiltration, including high-flux membranes are allowed as long as there is no plan to change the patient's regimen during the study.
• Sufficient iron stores, defined as serum ferritin ≥ 200 ng/ml and transferrin saturation ≥20%. (Patients not meeting these criteria may receive iron supplementation therapy during the Screening and stabilization period to appropriately correct their iron store deficiency to meet the criterion required for randomization);
• Ability to comply with study medication use, study visits, and study procedures as judged by the investigator;
• Females of childbearing potential agree to use an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) for the duration of the study.
• Qualified and willing to sign the informed consent form with the commitment of complying with all the scheduled visits, and study procedures as judged by the investigator;
• In any circumstances that potential participants are not able to give consent, it may be given by responsible parents or guardian.

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.