Trial Outcomes & Findings for Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis (NCT NCT03519243)
NCT ID: NCT03519243
Last Updated: 2021-03-04
Results Overview
The baseline hemoglobin will be calculated as the arithmetic mean of hemoglobin values obtained at screening and at Visit 1. The final hemoglobin value during the evaluation period will be calculated as the arithmetic mean of hemoglobin values obtained at Week 21 and Week 23.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Baseline - measurements on Screening (weeks -4 - 0) and on day 1; Evaluation period - weekly measures on weeks 21 to 23
Results posted on
2021-03-04
Participant Flow
Participant milestones
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 2,75 mcg/kg * Conversion Ratio
Subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
subcutaneously monthly
Mircera: subcutaneously monthly
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
0
|
25
|
|
Overall Study
COMPLETED
|
20
|
21
|
0
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis
Baseline characteristics by cohort
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
n=25 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
n=25 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
n=25 Participants
subcutaneously monthly
Mircera: subcutaneously monthly
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
54 years
n=7 Participants
|
47 years
n=5 Participants
|
55 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Belarus
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
20 participants
n=5 Participants
|
24 participants
n=7 Participants
|
23 participants
n=5 Participants
|
67 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline - measurements on Screening (weeks -4 - 0) and on day 1; Evaluation period - weekly measures on weeks 21 to 23The baseline hemoglobin will be calculated as the arithmetic mean of hemoglobin values obtained at screening and at Visit 1. The final hemoglobin value during the evaluation period will be calculated as the arithmetic mean of hemoglobin values obtained at Week 21 and Week 23.
Outcome measures
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
n=20 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
n=21 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
n=24 Participants
subcutaneously monthly
Mircera: subcutaneously monthly
|
|---|---|---|---|
|
Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
|
-3.25 g/L
Interval -12.0 to 0.5
|
3.5 g/L
Interval -7.0 to 14.0
|
-2.75 g/L
Interval -9.5 to 9.0
|
SECONDARY outcome
Timeframe: Week 23The proportion of patients, in each group, who developed СТСАЕ v. 4.03 Grade 3-4 AEs that, in the Investigator's opinion, are related to BCD-131 \- the proportion of patients, in each group, who discontinued the study due to AEs/SAEs
Outcome measures
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
n=25 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
n=25 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
n=25 Participants
subcutaneously monthly
Mircera: subcutaneously monthly
|
|---|---|---|---|
|
The Proportion of Patients Who Developed AEs/SAEs That, in the Investigator's Opinion, Are Related to BCD-131
|
5 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 9, 23Blood sampling for immunogenicity assessment (BAbs and NAbs) will be performed in all the patients included in the study before the first injection and then at Week 9 and Week 23. The immunogenicity endpoints will be analyzed after the completion of all periods of the study.
Outcome measures
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
n=24 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
n=25 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
n=25 Participants
subcutaneously monthly
Mircera: subcutaneously monthly
|
|---|---|---|---|
|
The Proportion of BAb- and NAb-positive Patients
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1Area under the concentration curve from the moment of injection to 672 h \[28 days\])
Outcome measures
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
n=15 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
n=15 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
n=15 Participants
subcutaneously monthly
Mircera: subcutaneously monthly
|
|---|---|---|---|
|
AUC(0-672 Hour)
|
51744.45 (mmol/L)*h
Interval 31201.8 to 87463.5
|
73948.8 (mmol/L)*h
Interval 57057.15 to 133730.25
|
89409.3 (mmol/L)*h
Interval 35389.95 to 166699.5
|
SECONDARY outcome
Timeframe: 3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1, weeks 5, 9, 13, 17, 21Area under the concentration curve from the moment of injection to infinity
Outcome measures
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
n=15 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
n=15 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
n=15 Participants
subcutaneously monthly
Mircera: subcutaneously monthly
|
|---|---|---|---|
|
AUC(0-∞)
|
65150.045 (mmol/L)*h
Interval 43463.791 to 91305.66
|
81698.001 (mmol/L)*h
Interval 63442.206 to 142665.693
|
96259.513 (mmol/L)*h
Interval 46985.695 to 192570.672
|
SECONDARY outcome
Timeframe: 3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1, weeks 5, 9, 13, 17, 21Maximum serum concentration of the drug product) after the first injection of the test/reference drug
Outcome measures
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
n=15 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
n=15 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
n=15 Participants
subcutaneously monthly
Mircera: subcutaneously monthly
|
|---|---|---|---|
|
Cmax
|
195.3 mmol/L
Interval 148.7 to 407.1
|
231.9 mmol/L
Interval 187.2 to 488.2
|
617.6 mmol/L
Interval 130.6 to 943.2
|
SECONDARY outcome
Timeframe: 3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1Area under the effect curve from the drug injection to 672 h \[28 days\]) based on the change in the absolute reticulocyte count after the first injection of the test/reference drug
Outcome measures
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
n=15 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
n=15 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
n=15 Participants
subcutaneously monthly
Mircera: subcutaneously monthly
|
|---|---|---|---|
|
AUEC(0-672 Hour)
|
7210.479 (cells*10^9)*h
Standard Deviation 5465.155
|
11274.380 (cells*10^9)*h
Standard Deviation 12460.177
|
12131.820 (cells*10^9)*h
Standard Deviation 15613.087
|
SECONDARY outcome
Timeframe: day 28Maximum absolute reticulocyte count after the first injection of BCD-131/Mircera®
Outcome measures
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
n=15 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
n=15 Participants
subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
n=15 Participants
subcutaneously monthly
Mircera: subcutaneously monthly
|
|---|---|---|---|
|
AC-Emax
|
96.650 (cells*10^9)/L
Standard Deviation 29.185
|
107.047 (cells*10^9)/L
Standard Deviation 38.615
|
154.753 (cells*10^9)/L
Standard Deviation 58.729
|
Adverse Events
BCD-131 1,05 mcg/kg * Conversion Ratio
Serious events: 6 serious events
Other events: 13 other events
Deaths: 1 deaths
BCD-131 1,7 mcg/kg * Conversion Ratio
Serious events: 4 serious events
Other events: 16 other events
Deaths: 2 deaths
Mircera
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
n=25 participants at risk
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
n=25 participants at risk
subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
n=25 participants at risk
subcutaneously monthly
Mircera: subcutaneously monthly
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
subcutaneous tissue
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
|
Nervous system disorders
consequence of stroke
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
|
Musculoskeletal and connective tissue disorders
fracture of the left ankle
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
|
Nervous system disorders
Hemorrhagic stroke
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
|
Cardiac disorders
Ischemic Heart Disease
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
|
Cardiac disorders
non-Q wave myocardial infarction
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
|
Vascular disorders
Arteriovenous Access Thrombosis
|
0.00%
0/25 • 25 weeks
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/25 • 25 weeks
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
|
Endocrine disorders
Type 2 diabetes. Diabetic foot syndrome
|
0.00%
0/25 • 25 weeks
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
|
Infections and infestations
Catheter-associated infection
|
0.00%
0/25 • 25 weeks
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
|
Vascular disorders
Phlebitis of the fistula vein
|
0.00%
0/25 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
|
Vascular disorders
arteriovenous fistula stenosis
|
0.00%
0/25 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
|
Gastrointestinal disorders
acute gastroenteritis
|
0.00%
0/25 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
Other adverse events
| Measure |
BCD-131 1,05 mcg/kg * Conversion Ratio
n=25 participants at risk
subcutaneously monthly
BCD-131: subcutaneously monthly
|
BCD-131 1,7 mcg/kg * Conversion Ratio
n=25 participants at risk
subcutaneously monthly
BCD-131: subcutaneously monthly
|
Mircera
n=25 participants at risk
subcutaneously monthly
Mircera: subcutaneously monthly
|
|---|---|---|---|
|
Vascular disorders
arterial pressure increase
|
16.0%
4/25 • Number of events 4 • 25 weeks
|
12.0%
3/25 • Number of events 3 • 25 weeks
|
12.0%
3/25 • Number of events 3 • 25 weeks
|
|
Investigations
lymphocytes decrease
|
16.0%
4/25 • Number of events 4 • 25 weeks
|
8.0%
2/25 • Number of events 2 • 25 weeks
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
|
Investigations
hyperglycemia
|
24.0%
6/25 • Number of events 6 • 25 weeks
|
16.0%
4/25 • Number of events 4 • 25 weeks
|
8.0%
2/25 • Number of events 2 • 25 weeks
|
|
Investigations
leukocytes decrease
|
8.0%
2/25 • Number of events 2 • 25 weeks
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
|
Investigations
neutrophils decrease
|
8.0%
2/25 • Number of events 2 • 25 weeks
|
8.0%
2/25 • Number of events 2 • 25 weeks
|
8.0%
2/25 • Number of events 2 • 25 weeks
|
|
Cardiac disorders
ECG changes
|
0.00%
0/25 • 25 weeks
|
8.0%
2/25 • Number of events 2 • 25 weeks
|
8.0%
2/25 • Number of events 2 • 25 weeks
|
|
Investigations
lymphocytes increase
|
4.0%
1/25 • Number of events 1 • 25 weeks
|
0.00%
0/25 • 25 weeks
|
8.0%
2/25 • Number of events 2 • 25 weeks
|
|
Vascular disorders
systolic blood pressure increase (isolated)
|
12.0%
3/25 • Number of events 3 • 25 weeks
|
24.0%
6/25 • Number of events 6 • 25 weeks
|
16.0%
4/25 • Number of events 4 • 25 weeks
|
|
Vascular disorders
dyastolic blood pressure increase (isolated)
|
8.0%
2/25 • Number of events 2 • 25 weeks
|
16.0%
4/25 • Number of events 4 • 25 weeks
|
24.0%
6/25 • Number of events 6 • 25 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place