Trial Outcomes & Findings for A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia (NCT NCT00661505)
NCT ID: NCT00661505
Last Updated: 2017-12-06
Results Overview
The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.
COMPLETED
PHASE3
132 participants
EEP (Week 16 to Week 24)
2017-12-06
Participant Flow
A total of 132 participants were enrolled in this study conducted from 14 May 2008 to 22 June 2010 at 20 centers in Turkey.
Participant milestones
| Measure |
C.E.R.A. 120, 200, or 360 mcg
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Overall Study
STARTED
|
132
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
C.E.R.A. 120, 200, or 360 mcg
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Protocol Violation
|
14
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
Baseline characteristics by cohort
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=131 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 13.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: EEP (Week 16 to Week 24)Population: The per protocol (PP) population included all participants who received at least one dose C.E.R.A. and underwent a safety follow-up except who had \< 3 recorded Hb values and had inadequate iron status during EEP, missed C.E.R.A administration during Weeks 16-24, and/or who withdrawn before the end of EEP.
The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=84 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period
|
46.43 Percentage of participants
Interval 35.47 to 57.65
|
SECONDARY outcome
Timeframe: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)Population: The Intention to treat (ITT) population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.
The mean change in the time-adjusted average Hb concentration between the two study periods The Stability Verification Period (SVP) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=127 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period
|
0.29 g/dL
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: EEP (Week 16 to Week 24)Population: The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available.
The time adjusted average Hb concentration of all the values recorded during the EEP was calculated for each participant. The percentage of participants maintaining their average Hb concentration during the EEP within the Hb concentration range of 10.0-12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=127 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
|
51.18 Percentage of participants
Interval 42.16 to 60.15
|
SECONDARY outcome
Timeframe: EEP (Week 16 to Week 24)Population: The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.
The Hb concentration was recorded for all the participants during the EEP. The median time spent (in days) by participants in the target range (10.0-12.0 g/dL) during the EEP is presented. The EEP was defined as Week 16 to Week 24.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=104 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period
|
38.0 days
Interval 21.5 to 51.0
|
SECONDARY outcome
Timeframe: EEP (Week 16 to Week 20)Population: The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.
The mean dose of C.E.R.A. required to maintain Hb level between 10.0-12.0 g/dL during the EEP was calculated per participant and then summarized. The EEP was defined as Week 16 to Week 24. However, C.E.R.A. was not administered at the Week 24 visit. Therefore, the time period for calculation of mean C.E.R.A. dose during EEP is from Week 16 to Week 20.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=33 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
|
103.5 mcg
Standard Deviation 46.95
|
SECONDARY outcome
Timeframe: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)Population: The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.0 and 12.0 g/dL throughout the dose titration period (DTP) and the EEP (Week 1 to Week 24). The reference Hb value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0).
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=127 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
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|---|---|
|
Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
DTP, n = 127
|
75.6 Percentage of participants
|
|
Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
EEP, n = 107
|
36.4 Percentage of participants
|
SECONDARY outcome
Timeframe: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)Population: The ITT population included participants who received at least 1 dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
The mean monthly dose of C.E.R.A. administered during the DTP and EEP was calculated per participant and then summarized.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=127 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
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|---|---|
|
Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
During DTP, n = 127
|
121.6 mcg
Standard Deviation 47.13
|
|
Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
During EEP, n = 107
|
112.4 mcg
Standard Deviation 76.78
|
SECONDARY outcome
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Mean change from Baseline in erythrocyte mean corpuscular volume (MCV) was calculated as the value at a specific week during the study minus the BL value. The Baseline was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=102 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
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|---|---|
|
Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24
Change from BL to Week 16, n = 102
|
-2.02 Femtoliter
Standard Deviation 3.58
|
|
Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24
Change from BL to Week 24, n = 95
|
-1.26 Femtoliter
Standard Deviation 3.77
|
SECONDARY outcome
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Mean change from Baseline (BL) in hematocrit was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=104 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change From Baseline in Hematocrit at Week 16 and Week 24
Change from BL to Week 16, n = 104
|
0.00 percentage of red blood cells
Standard Deviation 0.04
|
|
Mean Change From Baseline in Hematocrit at Week 16 and Week 24
Change from BL to Week 24, n = 99
|
0.01 percentage of red blood cells
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Mean change from BL in hemoglobin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=104 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change From Baseline in Hemoglobin at Week 16 and Week 24
Change from BL to Week 16, n = 104
|
-0.00 g/dL
Standard Deviation 1.16
|
|
Mean Change From Baseline in Hemoglobin at Week 16 and Week 24
Change from BL to Week 24, n = 98
|
0.22 g/dL
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Mean change from BL in for each parameter (leucocytes and platelet) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=102 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24
Leucocytes, Change from BL to Week 16, n = 102
|
0.27 Number of cells x 10^9/L
Standard Deviation 2.21
|
|
Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24
Leucocytes, Change from BL to Week 24, n = 95
|
-0.03 Number of cells x 10^9/L
Standard Deviation 1.58
|
|
Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24
Platelet, Change from BL to Week 16, n = 102
|
2.56 Number of cells x 10^9/L
Standard Deviation 51.21
|
|
Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24
Platelet, Change from BL to Week 24, n = 96
|
0.17 Number of cells x 10^9/L
Standard Deviation 55.01
|
SECONDARY outcome
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Mean change from BL in ferritin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=93 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change From Baseline in Ferritin at Week 16 and Week 24
Change from BL to Week 16, n = 93
|
20.80 microgram/liter
Standard Deviation 283.54
|
|
Mean Change From Baseline in Ferritin at Week 16 and Week 24
Change from BL to Week 24, n = 75
|
31.51 microgram/liter
Standard Deviation 385.22
|
SECONDARY outcome
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Mean change from BL in each parameter \[iron, total iron binding capacity (TIBC), and creatinine\] was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=98 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
Iron, Change from BL to Week 16, n = 98
|
2.08 micromole/Liter
Standard Deviation 6.87
|
|
Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
Iron, Change from BL to Week 24, n = 93
|
1.15 micromole/Liter
Standard Deviation 6.07
|
|
Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
TIBC, Change from BL to Week 16, n = 84
|
0.24 micromole/Liter
Standard Deviation 7.09
|
|
Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
TIBC, Change from BL to Week 24, n = 80
|
0.05 micromole/Liter
Standard Deviation 8.25
|
|
Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
Creatinine, Change from BL to Week 16, n = 2
|
-20.33 micromole/Liter
Standard Deviation 363.80
|
|
Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
Creatinine, Change from BL to Week 24, n = 92
|
16.73 micromole/Liter
Standard Deviation 218.73
|
SECONDARY outcome
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Mean change from BL in each parameter (transferrin and albumin) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=98 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24
Transferrin, Change from BL to Week 16, n = 33
|
0.19 gram/liter
Standard Deviation 0.46
|
|
Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24
Transferrin, Change from BL to Week 24, n = 29
|
0.09 gram/liter
Standard Deviation 0.32
|
|
Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24
Albumin, Change from BL to Week 16, n = 98
|
0.13 gram/liter
Standard Deviation 3.92
|
|
Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24
Albumin, Change from BL to Week 24, n = 93
|
-0.22 gram/liter
Standard Deviation 4.58
|
SECONDARY outcome
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Mean change from BL in transferrin saturation (TSAT) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=89 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24
Change from BL to Week 16, n = 89
|
4.11 Percentage of TSAT
Standard Deviation 20.35
|
|
Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24
Change from BL to Week 24, n = 86
|
2.41 Percentage of TSAT
Standard Deviation 20.18
|
SECONDARY outcome
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Mean change from BL in C-reactive protein was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=88 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24
Change from BL to Week 16, n = 88
|
1.92 milligram/liter
Standard Deviation 20.64
|
|
Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24
Change from BL to Week 16, n = 81
|
-1.43 milligram/liter
Standard Deviation 20.71
|
SECONDARY outcome
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Mean change from BL in each parameter (phosphate and potassium) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=97 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24
Phosphate, Change from BL to Week 16, n = 97
|
0.04 millimole/liter
Standard Deviation 0.54
|
|
Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24
Phosphate, Change from BL to Week 24, n = 94
|
0.06 millimole/liter
Standard Deviation 0.62
|
|
Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24
Potassium, Change from BL to Week 16, n = 94
|
-0.04 millimole/liter
Standard Deviation 0.93
|
|
Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24
Potassium, Change from BL to Week 24, n = 95
|
-0.02 millimole/liter
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: BL (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Mean change from BL in weight was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=103 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change From Baseline in Weight at Week 16 and Week 24
Change from BL to Week 16, n = 103
|
0.5 kilogram
Standard Deviation 4.17
|
|
Mean Change From Baseline in Weight at Week 16 and Week 24
Change from BL to Week 24, n = 100
|
0.7 kilogram
Standard Deviation 4.24
|
SECONDARY outcome
Timeframe: Baseline (Week -4 to Week 0), Week 16, and Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before blood sampling and C.E.R.A. administration. Blood pressure was assessed both before and after the dialysis session for participants undergoing hemodialysis. Change from BL in blood pressure was calculated as the value at a specific week (W) during the study minus the BL value. The baseline was defined as Week -4 to Week 0.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=105 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
SBP Before Dialysis,Change from BL to W 16,n = 105
|
2.1 Millimeters of Mercury
Standard Deviation 14.94
|
|
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
DBP Before Dialysis,Change from BL to W 16,n = 105
|
2.4 Millimeters of Mercury
Standard Deviation 10.61
|
|
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
SBP Before Dialysis,Change from BL to W 24,n = 101
|
3.0 Millimeters of Mercury
Standard Deviation 15.46
|
|
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
DBP Before Dialysis,Change from BL to W 24,n = 101
|
2.2 Millimeters of Mercury
Standard Deviation 11.24
|
|
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
SBP After Dialysis,Change from BL to W 16, n = 100
|
-0.3 Millimeters of Mercury
Standard Deviation 17.54
|
|
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
DBP After Dialysis,Change from BL to W 16, n = 100
|
1.7 Millimeters of Mercury
Standard Deviation 10.91
|
|
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
SBP After Dialysis,Change from BL to W 24, n = 95
|
1.0 Millimeters of Mercury
Standard Deviation 15.88
|
|
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
DBP After Dialysis, Change from BL to W 24, n = 95
|
1.8 Millimeters of Mercury
Standard Deviation 10.94
|
SECONDARY outcome
Timeframe: Up to Week 28Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
The number of participants taking different classes of concomitant medications at any time following enrollment into the study is presented.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=131 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Number of Participants Taking Concomitant Medications
Antibacterials for systemic use
|
13 Number of participants
|
|
Number of Participants Taking Concomitant Medications
Vitamins
|
13 Number of participants
|
|
Number of Participants Taking Concomitant Medications
Vaccines
|
7 Number of participants
|
|
Number of Participants Taking Concomitant Medications
Agents acting on the renin-angiotensin system
|
5 Number of participants
|
|
Number of Participants Taking Concomitant Medications
Analgesics
|
4 Number of participants
|
|
Number of Participants Taking Concomitant Medications
Antianemic preparations
|
4 Number of participants
|
|
Number of Participants Taking Concomitant Medications
Antithrombotic agents
|
4 Number of participants
|
|
Number of Participants Taking Concomitant Medications
Drug for acid related disorders
|
4 Number of participants
|
|
Number of Participants Taking Concomitant Medications
Mineral supplements
|
4 Number of participants
|
|
Number of Participants Taking Concomitant Medications
Other
|
4 Number of participants
|
SECONDARY outcome
Timeframe: Up to Week 28Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=131 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Number of Participants With Any Adverse Events and Serious Adverse Events
Number of participants with any AE
|
44 Number of participants
|
|
Number of Participants With Any Adverse Events and Serious Adverse Events
Number of participants with any SAE
|
13 Number of participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
The number of participants with Anti-epoetin antibodies is presented.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=131 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Number of Participants With Reports of Anti-erythropoietin Antibodies
|
0 Number of participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 24Population: The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
Red blood cell transfusions were permitted during the DTP and EEP (Week 1 to Week 24) in case of medical need. All participants requiring a blood transfusion were withdrawn from the study. The number of participants who were administered RBC transfusions during the DTP and EEP is presented.
Outcome measures
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=131 Participants
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period
During DTP
|
1 Number of participants
|
|
Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period
During EEP
|
0 Number of participants
|
Adverse Events
C.E.R.A. 120, 200, or 360 mcg
Serious adverse events
| Measure |
C.E.R.A. 120, 200, or 360 mcg
n=131 participants at risk
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Angina pectoris
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Atrial fibrillation
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
2/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Vomiting
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Bacteraemia
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Urinary tract infection
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Ischaemic stroke
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Surgical and medical procedures
Renal transplant
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.76%
1/131 • Up to Week 28
Adverse events were analyzed for the safety population which included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.
|
Other adverse events
Adverse event data not reported
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER