Trial Outcomes & Findings for Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients (NCT NCT03408639)
NCT ID: NCT03408639
Last Updated: 2019-12-18
Results Overview
The primary endpoints of this study is to assess mean Hb change level during the last four weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
156 participants
Primary outcome timeframe
Week 22 to week 26
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
CinnaPoietin®
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
78
|
|
Overall Study
COMPLETED
|
67
|
56
|
|
Overall Study
NOT COMPLETED
|
11
|
22
|
Reasons for withdrawal
| Measure |
CinnaPoietin®
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
Overall Study
Death
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
7
|
|
Overall Study
Physician Decision
|
3
|
6
|
Baseline Characteristics
Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
CinnaPoietin®
n=78 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=78 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
55.02 years
STANDARD_DEVIATION 11.38 • n=5 Participants
|
50.01 years
STANDARD_DEVIATION 12.72 • n=7 Participants
|
52.53 years
STANDARD_DEVIATION 12.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Iran
|
78 participants
n=5 Participants
|
78 participants
n=7 Participants
|
156 participants
n=5 Participants
|
|
Hemoglobin concentration
|
10.41 g/dL
STANDARD_DEVIATION 0.89 • n=5 Participants
|
10.64 g/dL
STANDARD_DEVIATION 0.82 • n=7 Participants
|
10.53 g/dL
STANDARD_DEVIATION 0.86 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 22 to week 26The primary endpoints of this study is to assess mean Hb change level during the last four weeks of treatment.
Outcome measures
| Measure |
CinnaPoietin®
n=61 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=38 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
Mean Hb Change Level During the Last Four Weeks of Treatment
|
0.4 g/dL
Standard Deviation 1.26
|
0.74 g/dL
Standard Deviation 1.39
|
PRIMARY outcome
Timeframe: Week 22 to week 26The 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.
Outcome measures
| Measure |
CinnaPoietin®
n=46 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=19 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment
|
117.02 IU/Kg/week
Standard Deviation 54.5
|
110.01 IU/Kg/week
Standard Deviation 49.27
|
SECONDARY outcome
Timeframe: 26 weeksThe proportion of patients with any permanent or transient dose change during 26 weeks.
Outcome measures
| Measure |
CinnaPoietin®
n=72 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=66 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
The Proportion of Patients With Any Permanent or Transient Dose Change
|
0.9 proportion of patients
|
0.95 proportion of patients
|
SECONDARY outcome
Timeframe: 26 weeksThe proportion of patients with any Hb measurement outside the target range (10-12 g/dl) during 26 weeks.
Outcome measures
| Measure |
CinnaPoietin®
n=74 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=73 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)
|
0.92 proportion of patients
|
1 proportion of patients
|
SECONDARY outcome
Timeframe: 26 weeksThe proportion of patients needed blood transfusions during 26 weeks.
Outcome measures
| Measure |
CinnaPoietin®
n=78 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=78 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
The Proportion of Patients Needed Blood Transfusions
|
0.04 proportion of patients
|
0.04 proportion of patients
|
SECONDARY outcome
Timeframe: Week 12 to week 26Treatment 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
Outcome measures
| Measure |
CinnaPoietin®
n=54 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=25 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
The Proportion of Patients With Treatment Success
|
0.41 proportion of patients
|
0.44 proportion of patients
|
SECONDARY outcome
Timeframe: 26 weeksMaintenance 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
Outcome measures
| Measure |
CinnaPoietin®
n=68 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=56 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
The Proportion of Patients With Maintenance Success
|
0.71 proportion of patients
|
0.43 proportion of patients
|
SECONDARY outcome
Timeframe: Week 22 to week 26The percentage of patients with Hb measurements more than 10.0 g/dl from week 22 to week 26.
Outcome measures
| Measure |
CinnaPoietin®
n=68 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=56 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
The Percentage of Patients With Hb Measurements More Than 10.0 g/dl
|
55 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Week 22 to week 26The percentage of patients with hematocrit measurements more than 30% from week 22 to week 26.
Outcome measures
| Measure |
CinnaPoietin®
n=68 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=56 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
The Percentage of Patients With Hematocrit Measurements More Than 30%
|
86.76 percentage of patients
|
92.86 percentage of patients
|
SECONDARY outcome
Timeframe: 26 weeksThe first safety endpoint is the proportion of patients with at least one Hb measurement above 13 g/dL.
Outcome measures
| Measure |
CinnaPoietin®
n=70 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=59 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
The Incidence of Hb Levels Above 13 g/dl
|
31 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 26 weeksThe proportion of patients with an increase in Hb concentration of \> 1.0 g/dl for four consecutive weeks during 26 weeks.
Outcome measures
| Measure |
CinnaPoietin®
n=72 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=65 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
The Proportion of Patients With an Increase in Hb Concentration of > 1.0 g/dl for Four Consecutive Weeks
|
44 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: 26 weeksThe incidence of adverse events during 26 weeks.
Outcome measures
| Measure |
CinnaPoietin®
n=78 Participants
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=78 Participants
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
The Incidence of Adverse Events
|
23 Participants
|
18 Participants
|
Adverse Events
CinnaPoietin®
Serious events: 14 serious events
Other events: 11 other events
Deaths: 5 deaths
Eprex®
Serious events: 7 serious events
Other events: 12 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
CinnaPoietin®
n=78 participants at risk
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=78 participants at risk
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
Cardiac disorders
Palpitation, Cardiac Function Impairment, Cardiac Infraction, Chest Pain, Tachycardia)
|
2.6%
2/78 • 26 weeks
|
3.8%
3/78 • 26 weeks
|
|
Renal and urinary disorders
Inflation on Ankle
|
1.3%
1/78 • 26 weeks
|
0.00%
0/78 • 26 weeks
|
|
General disorders
(Skin reaction, Catheter defect, Disability catheter, Filter clots, pain in injection site, skin rea
|
5.1%
4/78 • 26 weeks
|
0.00%
0/78 • 26 weeks
|
|
Hepatobiliary disorders
Gallstones
|
1.3%
1/78 • 26 weeks
|
0.00%
0/78 • 26 weeks
|
|
Infections and infestations
(Pneumonia, Infection of right hand Lower than the fistula)
|
2.6%
2/78 • 26 weeks
|
0.00%
0/78 • 26 weeks
|
|
Injury, poisoning and procedural complications
(CO toxicity, transplantation complication)
|
0.00%
0/78 • 26 weeks
|
2.6%
2/78 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
(tearing of tendon in both knees, back pain, Musculoskeletal-Bone pain, knee tenderness due to joint
|
2.6%
2/78 • 26 weeks
|
1.3%
1/78 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
(Respiratory disorder, chest pain and dyspenea, dyspnea)
|
1.3%
1/78 • 26 weeks
|
0.00%
0/78 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
echymosis due to recent car accident, itching)
|
0.00%
0/78 • 26 weeks
|
1.3%
1/78 • 26 weeks
|
|
Surgical and medical procedures
Cardiac pacemaker AND Valve Replacement, orthopedic surgery)
|
1.3%
1/78 • 26 weeks
|
0.00%
0/78 • 26 weeks
|
Other adverse events
| Measure |
CinnaPoietin®
n=78 participants at risk
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.
In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
CinnaPoietin®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
Eprex®
n=78 participants at risk
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. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.
Eprex®: 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: Nephrovit tablet is daily administered to all the patients.
Vitamin B12 Injection: Vitamin B12 is monthly injected to all the patients.
|
|---|---|---|
|
Blood and lymphatic system disorders
(Eosinophilia, Thrombocytopenia)
|
0.00%
0/78 • 26 weeks
|
1.3%
1/78 • 26 weeks
|
|
Cardiac disorders
(Palpitation, Cardiac Function Impairment, Cardiac Infraction, Chest Pain, Tachycardia)
|
1.3%
1/78 • 26 weeks
|
3.8%
3/78 • 26 weeks
|
|
General disorders
(Skin reaction, Catheter defect, Disability catheter, Filter clots, pain in injection site, skin rea
|
3.8%
3/78 • 26 weeks
|
1.3%
1/78 • 26 weeks
|
|
Infections and infestations
(Pneumonia, Infection of right hand Lower than the fistula)
|
1.3%
1/78 • 26 weeks
|
0.00%
0/78 • 26 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/78 • 26 weeks
|
1.3%
1/78 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
(tearing of tendon in both knees, back pain, Musculoskeletal-Bone pain, knee tenderness due to joint
|
0.00%
0/78 • 26 weeks
|
1.3%
1/78 • 26 weeks
|
|
Nervous system disorders
(numbness in the wrist, dizziness)
|
1.3%
1/78 • 26 weeks
|
1.3%
1/78 • 26 weeks
|
|
Psychiatric disorders
Decreased libido
|
1.3%
1/78 • 26 weeks
|
0.00%
0/78 • 26 weeks
|
|
Reproductive system and breast disorders
vaginal discharge
|
0.00%
0/78 • 26 weeks
|
1.3%
1/78 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
(Respiratory disorder, chest pain and dyspenea, dyspnea)
|
2.6%
2/78 • 26 weeks
|
0.00%
0/78 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
(itching, echymosis due to recent car accident, itching)
|
0.00%
0/78 • 26 weeks
|
2.6%
2/78 • 26 weeks
|
|
Surgical and medical procedures
(Installing Cardiac pacemaker AND Valve Replacement, orthopedic surgery)
|
0.00%
0/78 • 26 weeks
|
1.3%
1/78 • 26 weeks
|
|
Vascular disorders
(blood clotting, Bleeding catheter, Hemorrage, Vascular disorders)
|
2.6%
2/78 • 26 weeks
|
0.00%
0/78 • 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator (PI) may publish results provided a copy of the written publication is received by the sponsor at least 30 days in advance for review and comment. If the parties disagree, PI agrees to meet with the sponsor before submission to resolve any disagreement. It is also agreed that publishing any reports from data is under the condition of the subject's consent. Any reports are highly confidential, and the PI does not have the permission to reveal them without the sponsor's agreement.
- Publication restrictions are in place
Restriction type: OTHER