Trial Outcomes & Findings for A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia (NCT NCT00882713)
NCT ID: NCT00882713
Last Updated: 2016-10-07
Results Overview
The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.
COMPLETED
PHASE3
202 participants
EEP (Week 17 to Week 24)
2016-10-07
Participant Flow
A total of 202 participants were enrolled in this study conducted from 12 February 2009 to 25 October 2010 at 28 study sites in Morocco.
Of 202 participants, 8 participants did not complete the stability verification period (SVP) of 4 weeks. Overall, 194 participants entered dose titration period (DTP) of 16 weeks.
Participant milestones
| Measure |
C.E.R.A.
Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A.) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Overall Study
STARTED
|
194
|
|
Overall Study
COMPLETED
|
172
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
C.E.R.A.
Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A.) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
3
|
|
Overall Study
Administrative reasons
|
4
|
|
Overall Study
refused treatment/withdrew consent
|
4
|
|
Overall Study
Blood transfusion
|
2
|
|
Overall Study
Insufficient therapeutic response
|
3
|
|
Overall Study
Failure to return
|
2
|
|
Overall Study
Other - Reasons
|
2
|
Baseline Characteristics
A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia
Baseline characteristics by cohort
| Measure |
C.E.R.A.
n=194 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Age, Continuous
|
51.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: EEP (Week 17 to Week 24)Population: The per-protocol (PP) population included all participants from the intention-to-treat (ITT) population, who fulfilled inclusion/exclusion criteria as per the study protocol. A total of 123 participants were included in the PP population.
The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.
Outcome measures
| Measure |
C.E.R.A.
n=123 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period
|
52.0 Percentage of participants
Interval 42.8 to 61.1
|
SECONDARY outcome
Timeframe: SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)Population: ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.
Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.
Outcome measures
| Measure |
C.E.R.A.
n=193 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period
|
0.48 g/dL
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: EEP (Week 17 to Week 24)Population: ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.
Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.
Outcome measures
| Measure |
C.E.R.A.
n=193 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP
|
60.6 Percentage of participants
Interval 53.4 to 67.6
|
SECONDARY outcome
Timeframe: EEP (Week 17 to Week 24)Population: ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.
Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.
Outcome measures
| Measure |
C.E.R.A.
n=193 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP
|
35.1 Days
Standard Deviation 19.85
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.
Outcome measures
| Measure |
C.E.R.A.
n=194 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Number of Participants With Any Adverse Events or Serious Adverse Events
Any AEs
|
39 Participants
|
|
Number of Participants With Any Adverse Events or Serious Adverse Events
Any SAEs
|
19 Participants
|
SECONDARY outcome
Timeframe: DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)Population: ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.
Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either \> or = 13 g/dL or \< or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was \> or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was \>1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.
Outcome measures
| Measure |
C.E.R.A.
n=193 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP
Dose adjustment during DTP (n = 193)
|
56 Percentage of participants
|
|
Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP
Dose adjustment during EEP (n = 185)
|
34.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.
Outcome measures
| Measure |
C.E.R.A.
n=194 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
During DTP
|
3 Number of RBCs transfusion
|
|
Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
During EEP
|
1 Number of RBCs transfusion
|
|
Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
During LTSP
|
2 Number of RBCs transfusion
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'.
The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A.
n=194 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Hemoglobin Levels Over Time
Hb at Week 0 (n = 194)
|
11.2 g/dL
Standard Deviation 0.58
|
|
Mean Hemoglobin Levels Over Time
Hb at Week 8 (n = 184)
|
11.7 g/dL
Standard Deviation 1.35
|
|
Mean Hemoglobin Levels Over Time
Hb at Week 16 (n = 175)
|
11.8 g/dL
Standard Deviation 1.21
|
|
Mean Hemoglobin Levels Over Time
Hb at Week 24 (n = 180)
|
11.8 g/dL
Standard Deviation 1.14
|
|
Mean Hemoglobin Levels Over Time
Hb at Week 32 (n = 177)
|
11.8 g/dL
Standard Deviation 1.23
|
|
Mean Hemoglobin Levels Over Time
Hb at Week 40 (n = 162)
|
11.8 g/dL
Standard Deviation 1.23
|
|
Mean Hemoglobin Levels Over Time
Hb at Week 48 (n = 168)
|
11.6 g/dL
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'.
The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A.
n=194 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Hematocrit Levels Over Time
HCT at Week 48 (n = 170)
|
0.35 Proportion of red blood cells in blood
Standard Deviation 0.04
|
|
Mean Hematocrit Levels Over Time
HCT at Week 0 (n = 194)
|
0.34 Proportion of red blood cells in blood
Standard Deviation 0.02
|
|
Mean Hematocrit Levels Over Time
HCT at Week 8 (n = 184)
|
0.36 Proportion of red blood cells in blood
Standard Deviation 0.04
|
|
Mean Hematocrit Levels Over Time
HCT at Week 16 (n = 175)
|
0.36 Proportion of red blood cells in blood
Standard Deviation 0.04
|
|
Mean Hematocrit Levels Over Time
HCT at Week 24 (n = 180)
|
0.36 Proportion of red blood cells in blood
Standard Deviation 0.04
|
|
Mean Hematocrit Levels Over Time
HCT at Week 32 (n = 177)
|
0.36 Proportion of red blood cells in blood
Standard Deviation 0.04
|
|
Mean Hematocrit Levels Over Time
HCT at Week 40 (n = 163)
|
0.36 Proportion of red blood cells in blood
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and a safety follow-up, whether withdrawn prematurely or not. Out of 194, one participant was excluded from the ITT population due to missing hemoglobin measurement and C.E.R.A medication after Week 0.
The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A.
n=193 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Albumin Levels Over Time
Albumin at Week 0 (n = 193)
|
43.1 g/L
Standard Deviation 8.61
|
|
Mean Albumin Levels Over Time
Albumin at Week 8 (n = 139)
|
41.0 g/L
Standard Deviation 6.65
|
|
Mean Albumin Levels Over Time
Albumin at Week 16 (n = 130)
|
41.3 g/L
Standard Deviation 6.44
|
|
Mean Albumin Levels Over Time
Albumin at Week 24 (n = 128)
|
40.2 g/L
Standard Deviation 6.19
|
|
Mean Albumin Levels Over Time
Albumin at Week 32 (n = 116)
|
39.9 g/L
Standard Deviation 6.12
|
|
Mean Albumin Levels Over Time
Albumin at Week 40 (n = 108)
|
40.4 g/L
Standard Deviation 6.47
|
|
Mean Albumin Levels Over Time
Albumin at Week 48 (n = 147)
|
39.9 g/L
Standard Deviation 7.26
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'.
The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A.
n=194 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean White Blood Cells and Thrombocytes Over Time
WBCs at Week 0 (n = 194)
|
6.5 10^9 cells/L
Standard Deviation 1.75
|
|
Mean White Blood Cells and Thrombocytes Over Time
WBCs at Week 8 (n = 153)
|
6.5 10^9 cells/L
Standard Deviation 2.00
|
|
Mean White Blood Cells and Thrombocytes Over Time
WBCs at Week 16 (n = 137)
|
6.3 10^9 cells/L
Standard Deviation 1.71
|
|
Mean White Blood Cells and Thrombocytes Over Time
WBCs at Week 24 (n = 138)
|
6.4 10^9 cells/L
Standard Deviation 2.00
|
|
Mean White Blood Cells and Thrombocytes Over Time
WBCs at Week 32 (n = 129)
|
6.3 10^9 cells/L
Standard Deviation 1.81
|
|
Mean White Blood Cells and Thrombocytes Over Time
WBCs at Week 40 (n = 123)
|
6.3 10^9 cells/L
Standard Deviation 1.78
|
|
Mean White Blood Cells and Thrombocytes Over Time
WBCs at Week 48 (n = 153)
|
6.5 10^9 cells/L
Standard Deviation 1.74
|
|
Mean White Blood Cells and Thrombocytes Over Time
Thrombocytes at Week 0 (n = 194)
|
213.9 10^9 cells/L
Standard Deviation 68.51
|
|
Mean White Blood Cells and Thrombocytes Over Time
Thrombocytes at Week 8 (n = 153)
|
207.5 10^9 cells/L
Standard Deviation 65.64
|
|
Mean White Blood Cells and Thrombocytes Over Time
Thrombocytes at Week 16 (n = 137)
|
202.5 10^9 cells/L
Standard Deviation 58.62
|
|
Mean White Blood Cells and Thrombocytes Over Time
Thrombocytes at Week 24 (n = 138)
|
200.5 10^9 cells/L
Standard Deviation 55.74
|
|
Mean White Blood Cells and Thrombocytes Over Time
Thrombocytes at Week 32 (n = 129)
|
208.6 10^9 cells/L
Standard Deviation 69.50
|
|
Mean White Blood Cells and Thrombocytes Over Time
Thrombocytes at Week 40 (n = 123)
|
206.1 10^9 cells/L
Standard Deviation 68.12
|
|
Mean White Blood Cells and Thrombocytes Over Time
Thrombocytes at Week 48 (n = 153)
|
204.7 10^9 cells/L
Standard Deviation 68.95
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'.
The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A.
n=194 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 0 (n = 194)
|
1.7 milimole/L
Standard Deviation 0.57
|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 8 (n = 139)
|
1.7 milimole/L
Standard Deviation 0.76
|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 16 (n = 131)
|
1.7 milimole/L
Standard Deviation 0.75
|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 24 (n = 130)
|
1.7 milimole/L
Standard Deviation 0.70
|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 32 (n = 116)
|
1.6 milimole/L
Standard Deviation 0.56
|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 40 (n = 110)
|
1.4 milimole/L
Standard Deviation 0.44
|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 48 (n = 148)
|
1.6 milimole/L
Standard Deviation 0.61
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 0 (n = 194)
|
5.3 milimole/L
Standard Deviation 0.91
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 8 (n = 139)
|
5.4 milimole/L
Standard Deviation 0.95
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 16 (n = 131)
|
5.4 milimole/L
Standard Deviation 0.99
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 24 (n = 130)
|
5.5 milimole/L
Standard Deviation 1.02
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 32 (n = 117)
|
5.5 milimole/L
Standard Deviation 0.92
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 40 (n = 110)
|
5.5 milimole/L
Standard Deviation 0.93
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 48 (n = 146)
|
5.3 milimole/L
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'.
The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A.
n=194 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 0 (n = 194)
|
775.7 micromole/L
Standard Deviation 477.80
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 8 (n = 139)
|
692.5 micromole/L
Standard Deviation 502.86
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 16 (n = 130)
|
676.1 micromole/L
Standard Deviation 490.80
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 24 (n = 130)
|
683.7 micromole/L
Standard Deviation 472.92
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 32 (n = 117)
|
670.2 micromole/L
Standard Deviation 477.22
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 40 (n = 110)
|
674.8 micromole/L
Standard Deviation 488.26
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 48 (n = 149)
|
699.6 micromole/L
Standard Deviation 444.93
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 0 (n = 194)
|
15.9 micromole/L
Standard Deviation 8.04
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 8 (n = 139)
|
15.1 micromole/L
Standard Deviation 7.49
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 16 (n = 129)
|
15.1 micromole/L
Standard Deviation 6.74
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 24 (n = 130)
|
14.3 micromole/L
Standard Deviation 5.08
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 32 (n = 116)
|
14.9 micromole/L
Standard Deviation 5.50
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 40 (n = 110)
|
15.6 micromole/L
Standard Deviation 5.59
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 48 (n = 148)
|
15.2 micromole/L
Standard Deviation 5.92
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 0 (n = 194)
|
44.5 micromole/L
Standard Deviation 11.46
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 8 (n = 137)
|
44.2 micromole/L
Standard Deviation 10.90
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 16 (n = 126)
|
44.8 micromole/L
Standard Deviation 12.40
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 24 (n = 123)
|
43.7 micromole/L
Standard Deviation 11.10
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 32 (n = 116)
|
44.1 micromole/L
Standard Deviation 11.33
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 40 (n = 110)
|
42.6 micromole/L
Standard Deviation 10.58
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 48 (n = 147)
|
44.0 micromole/L
Standard Deviation 10.37
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'.
The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A.
n=194 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 0 (n = 190)
|
6.9 miligrams/L
Standard Deviation 8.84
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 8 (n = 139)
|
7.9 miligrams/L
Standard Deviation 8.98
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 16 (n = 130)
|
8.6 miligrams/L
Standard Deviation 11.19
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 24 (n = 127)
|
9.3 miligrams/L
Standard Deviation 13.87
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 32 (n = 112)
|
7.1 miligrams/L
Standard Deviation 7.33
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 40 (n = 109)
|
7.2 miligrams/L
Standard Deviation 7.77
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 48 (n = 140)
|
7.4 miligrams/L
Standard Deviation 8.76
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'.
The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A.
n=194 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Ferritin Levels Over Time
Ferritin at Week 0 (n = 194)
|
547.6 mcg/L
Standard Deviation 896.63
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 8 (n = 138)
|
522.2 mcg/L
Standard Deviation 772.16
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 16 (n = 129)
|
517.6 mcg/L
Standard Deviation 639.09
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 24 (n = 128)
|
508.6 mcg/L
Standard Deviation 577.75
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 32 (n = 116)
|
522.6 mcg/L
Standard Deviation 874.94
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 40 (n = 110)
|
562.8 mcg/L
Standard Deviation 984.72
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 48 (n = 148)
|
505.6 mcg/L
Standard Deviation 770.48
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by 'n'.
The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A.
n=194 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 0 (n = 194)
|
37.3 Percentage of Transferrin Saturation
Standard Deviation 20.16
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 8 (n = 136)
|
35.0 Percentage of Transferrin Saturation
Standard Deviation 16.38
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 16 (n = 125)
|
36.0 Percentage of Transferrin Saturation
Standard Deviation 18.45
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 24 (n = 123)
|
34.9 Percentage of Transferrin Saturation
Standard Deviation 18.24
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 32 (n = 115)
|
35.4 Percentage of Transferrin Saturation
Standard Deviation 14.72
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 40 (n = 110)
|
38.0 Percentage of Transferrin Saturation
Standard Deviation 15.66
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 48 (n = 147)
|
36.5 Percentage of Transferrin Saturation
Standard Deviation 17.56
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by 'n'.
Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).
Outcome measures
| Measure |
C.E.R.A.
n=190 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Change From Baseline in Pulse Rate Over Time
Week 8 (n = 175)
|
0.37 beats per minute
Standard Deviation 6.21
|
|
Mean Change From Baseline in Pulse Rate Over Time
Week 16 (n = 175)
|
0.02 beats per minute
Standard Deviation 6.61
|
|
Mean Change From Baseline in Pulse Rate Over Time
Week 24 (n = 173)
|
0.30 beats per minute
Standard Deviation 6.86
|
|
Mean Change From Baseline in Pulse Rate Over Time
Week 32 (n = 173)
|
0.40 beats per minute
Standard Deviation 6.97
|
|
Mean Change From Baseline in Pulse Rate Over Time
Week 40 (n = 174)
|
0.52 beats per minute
Standard Deviation 8.24
|
|
Mean Change From Baseline in Pulse Rate Over Time
Week 48 (n = 190)
|
0.76 beats per minute
Standard Deviation 8.69
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by 'n'.
Mean change in blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).
Outcome measures
| Measure |
C.E.R.A.
n=191 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP before dialysis at Week 8 (n = 189)
|
1.15 millimeter of mercury
Standard Deviation 14.41
|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP before dialysis at Week 16 (n = 185)
|
-0.78 millimeter of mercury
Standard Deviation 13.08
|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP before dialysis at Week 24 (n = 182)
|
-0.58 millimeter of mercury
Standard Deviation 13.14
|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP before dialysis at Week 32 (n = 181)
|
-1.28 millimeter of mercury
Standard Deviation 14.68
|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP before dialysis at Week 40 (n = 175)
|
0.27 millimeter of mercury
Standard Deviation 13.24
|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP before dialysis at Week 48 (n = 191)
|
-0.52 millimeter of mercury
Standard Deviation 13.72
|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP after dialysis at Week 8 (n = 185)
|
1.68 millimeter of mercury
Standard Deviation 12.62
|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP after dialysis at Week 16 (n = 181)
|
0.48 millimeter of mercury
Standard Deviation 12.94
|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP after dialysis at Week 24 (n = 178)
|
0.60 millimeter of mercury
Standard Deviation 13.10
|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP after dialysis at Week 32 (n = 177)
|
0.40 millimeter of mercury
Standard Deviation 14.45
|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP after dialysis at Week 40 (n = 171)
|
1.22 millimeter of mercury
Standard Deviation 11.97
|
|
Mean Change From Baseline in Blood Pressure Over Time
SBP after dialysis at Week 48 (n = 187)
|
1.63 millimeter of mercury
Standard Deviation 13.97
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP before dialysis at Week 8 (n = 189)
|
-0.77 millimeter of mercury
Standard Deviation 11.85
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP before dialysis at Week 16 (n = 185)
|
-1.87 millimeter of mercury
Standard Deviation 11.00
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP before dialysis at Week 24 (n = 182)
|
-1.58 millimeter of mercury
Standard Deviation 11.56
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP before dialysis at Week 32 (n = 181)
|
-2.08 millimeter of mercury
Standard Deviation 9.56
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP before dialysis at Week 40 (n = 175)
|
-1.35 millimeter of mercury
Standard Deviation 10.23
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP before dialysis at Week 48 (n = 191)
|
-0.90 millimeter of mercury
Standard Deviation 10.72
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP after dialysis at Week 8 (n = 185)
|
-0.40 millimeter of mercury
Standard Deviation 9.04
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP after dialysis at Week 16 (n = 181)
|
-0.11 millimeter of mercury
Standard Deviation 10.35
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP after dialysis at Week 24 (n = 178)
|
-0.90 millimeter of mercury
Standard Deviation 9.47
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP after dialysis at Week 32 (n = 177)
|
-1.07 millimeter of mercury
Standard Deviation 8.56
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP after dialysis at Week 40 (n = 171)
|
-1.50 millimeter of mercury
Standard Deviation 8.95
|
|
Mean Change From Baseline in Blood Pressure Over Time
DBP after dialysis at Week 48 (n = 187)
|
-1.21 millimeter of mercury
Standard Deviation 10.11
|
SECONDARY outcome
Timeframe: Week 16 and Week 48Population: Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by 'n'.
Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).
Outcome measures
| Measure |
C.E.R.A.
n=191 Participants
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Mean Change From Baseline in Weight Over Time
Week 16 (n = 185)
|
-0.20 kilogram
Standard Deviation 3.17
|
|
Mean Change From Baseline in Weight Over Time
Week 48 (n = 191)
|
0.06 kilogram
Standard Deviation 3.21
|
Adverse Events
C.E.R.A.
Serious adverse events
| Measure |
C.E.R.A.
n=194 participants at risk
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Cardiac disorder
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
General disorders
Asthenia
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
General disorders
Drug effect decreased
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Pneumonia
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.5%
3/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Convulsion
|
0.52%
1/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Vascular disorders
Hypertension
|
2.1%
4/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
Other adverse events
| Measure |
C.E.R.A.
n=194 participants at risk
Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms \[mcg\]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
2/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Bronchitis
|
5.7%
11/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
|
Vascular disorders
Hypotension
|
1.0%
2/194 • Up to Week 52
Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.
|
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