Anemia in End-Stage Renal Disease Clinical Trial
Official title:
A Phase III, Randomized, Two Armed, Parallel, Double Blind (Patient and Assessor Blinded), Active Controlled Non Inferiority 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 Hemodialysis Patients
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®.
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.
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