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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
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.
Javad-al-Aemeh clinic
Kerman, Iran
SHAFA Hospital
Kerman, Iran
Haj Ebrahimi dialysis center
Shiraz, Iran
Ghiasi hospital
Tehran, Iran
Hashemi Nezhad Hospital
Tehran, Iran
Imam Hussein Hospital
Tehran, Iran
Madar dialysis center
Tehran, Iran
Milad Hospital
Tehran, Iran
Mean Hb Change Level During the Last Four Weeks of Treatment
The primary endpoints of this study is to assess mean Hb change level during the last four weeks of treatment.
Time frame: Week 22 to week 26
Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment
The mean weekly epoetin dosage per kg body weight during the last four weeks of treatment necessary to maintain the Hb level within 10-12 g/dl during the last four weeks of treatment is considered as the second primary endpoint.
Time frame: Week 22 to week 26
The Proportion of Patients With Any Permanent or Transient Dose Change
The proportion of patients with any permanent or transient dose change during 26 weeks.
Time frame: 26 weeks
The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)
The proportion of patients with any Hb measurement outside the target range (10-12 g/dl) during 26 weeks.
Time frame: 26 weeks
The Proportion of Patients Needed Blood Transfusions
The proportion of patients needed blood transfusions during 26 weeks.
Time frame: 26 weeks
The Proportion of Patients With Treatment Success
Treatment success is considered as Hb concentration equal to or more than 11.0 g/dl and two consecutive weeks without any blood transfusion within the preceding three months
Time frame: Week 12 to week 26
The Proportion of Patients With Maintenance Success
Maintenance success is considered as maintenance success is considered as maintenance of mean Hb concentration of 11.0 ± 1.0 g/dl for at least four consecutive weeks
Time frame: 26 weeks
The Percentage of Patients With Hb Measurements More Than 10.0 g/dl
The percentage of patients with Hb measurements more than 10.0 g/dl from week 22 to week 26.
Time frame: Week 22 to week 26
The Percentage of Patients With Hematocrit Measurements More Than 30%
The percentage of patients with hematocrit measurements more than 30% from week 22 to week 26.
Time frame: Week 22 to week 26
The Incidence of Hb Levels Above 13 g/dl
The first safety endpoint is the proportion of patients with at least one Hb measurement above 13 g/dL.
Time frame: 26 weeks
The Proportion of Patients With an Increase in Hb Concentration of > 1.0 g/dl for Four Consecutive Weeks
The proportion of patients with an increase in Hb concentration of \> 1.0 g/dl for four consecutive weeks during 26 weeks.
Time frame: 26 weeks
The Incidence of Adverse Events
The incidence of adverse events during 26 weeks.
Time frame: 26 weeks
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