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

Launched by CINNAGEN · Jan 23, 2018

Keywords

ClinConnect Summary

This study is a phase III, randomized, two-armed, parallel, double-blind (patient and assessor blinded), active-controlled noninferiority clinical trial to determine the non-inferior therapeutic efficacy and safety between CinnaPoietin® (Beta erythropoietin) and Eprex® (epoetin alpha) on the treatment of anemia in ESRD patient under hemodialysis. After signing the written informed consents, 156 patients have been planned to randomize and assign to receive CinnaPoietin® or Eprex® for a 26-weeks period. Administration dose for patients who are treated with erythropoietin is the similar dose o...

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Eligibility criteria

• 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.