Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients
Condition: Anemia in End-Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase III, randomized, two-armed, parallel, double-blind, active-controlled clinical
      trial is designed to compare efficacy and safety of CinnaPoietin® (Beta erythropoietin) and
      Eprex® (epoetin alpha) on the treatment of anemia in 156 End-Stage Renal Disease hemodialysis
      patients. 156 patients have been planned to randomize and assign to receive CinnaPoietin® or
      Eprex® for a 26-week period. Administration dose for patients who are treated with
      erythropoietin is the similar dose of the previously administered amount (IV or SC without
      any change). After then, dose adjustment will be made based on patients' response. The
      primary objective of this study is to compare the efficacy of CinnaPoietin® with Eprex®. The
      secondary objectives of this study are further comparison and evaluation of efficacy along
      with safety between CinnaPoietin® and Eprex®.
    

Detailed description: 
      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 of the previously administered amount
      (IV or SC without any change). After then, dose adjustment will be made based on patients'
      response. In addition to main intervention, Nephrovit tablet/day and B12 100 mcg/month were
      prescribed for patients. The primary objective of this study is to compare the efficacy of
      CinnaPoietin® with Eprex®. The secondary objectives of this study are further comparison and
      evaluation of efficacy and safety.

      The clinical trial will be conducted according to the GCP considerations. A comprehensive
      validation check program is used to verify the data, and discrepancy reports are generated
      accordingly for resolution by the investigator.

      In order to ensure the use of standard and unified procedure of each test, monitoring of each
      site and laboratory site are going to be applied by sponsor monitoring team and CRO as
      external monitoring team.

      The same prefilled syringe is used for CinnaPoietin® to be sure that there is no difference
      between CinnaPoietin® and Eprex® as brand drug. The drugs will be relabeled, and the same
      label is used for both prefilled syringe. So neither investigators nor subjects are able to
      notice any differences between them and are blind to the assignment.

      Determination of sample size 156 patients will be equally (1:1) divided into intervention
      arms (78 in each group considering drop out) for achieving 80% power in order to determine
      non-inferiority using a one-sided, independent sample t-test. The margin of non-inferiority
      is -1.00.

      The true difference between the means is assumed to be -0.500. The significance level (alpha)
      of the test is 0.05. The data are drawn from populations with standard deviations of 1.200
      and 1.200.
    

Intervention name(s): CinnaPoietin®; Eprex®; Nephrovit; Vitamin B12 Injection
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.; The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.; Nephrovit tablet is daily administered to all the patients.; Vitamin B12 is monthly injected to all the patients.
Other intervention name(s): Beta erythropoietin; Epoetin alpha
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin; Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: End-Stage Renal Disease, Anemia, Erythropoietin, Hemoglobin