Trial Outcomes & Findings for LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia. (NCT NCT00517413)
NCT ID: NCT00517413
Last Updated: 2016-04-29
Results Overview
The haemoglobin (Hb) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The reference Hb value was defined on the basis of individual participant's all assessments at Weeks -4, -3, -2, -1 and 0. The Hb value on the first day of first dose (Week 0) was included in the calculation, as this assessment was performed before the first dose was given. The percentage of participants maintaining their mean Hb concentration within +/-1.0 gram/deciliter (g/dL) of their reference Hb and between 10.5 and 12.5 g/dL are reported for efficacy evaluation period (EEP). Efficacy evaluation period was from Week 16 to Week 24 after completion of 16-week dose titration period (DTP).
COMPLETED
PHASE3
163 participants
EEP (Week 16 to 24)
2016-04-29
Participant Flow
A total of 261 participants were screened and 163 participants were enrolled from 26 centers in 9 countries (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay, Venezuela) from 08 October 2007 to 15 May 2010.
Participant milestones
| Measure |
C.E.R.A
Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta \[Mircera\]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Overall Study
STARTED
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163
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|
Overall Study
COMPLETED
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102
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Overall Study
NOT COMPLETED
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61
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Reasons for withdrawal
| Measure |
C.E.R.A
Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta \[Mircera\]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Overall Study
Adverse Event
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7
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Overall Study
Death
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13
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Overall Study
Protocol Violation
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15
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Overall Study
Withdrawal by Subject
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2
|
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Overall Study
Failure to return
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1
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Overall Study
Other-Reasons
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23
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Baseline Characteristics
LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Baseline characteristics by cohort
| Measure |
C.E.R.A
n=161 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Age, Continuous
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53.7 Years
STANDARD_DEVIATION 14.95 • n=5 Participants
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Sex: Female, Male
Female
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67 Participants
n=5 Participants
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Sex: Female, Male
Male
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94 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: EEP (Week 16 to 24)Population: The Per-Protocol Population (PP) included all participants in the safety population except those who had \<3 recorded Hb values; withdrawn; inadequate iron defined as mean serum ferritin =\<100 nanogram/milliliter (ng/mL) or mean TSAT=\<20% or mean hypochromic RBCs\>=10%; or had missing administration of C.E.R.A. all during EEP (Week 16-24).
The haemoglobin (Hb) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The reference Hb value was defined on the basis of individual participant's all assessments at Weeks -4, -3, -2, -1 and 0. The Hb value on the first day of first dose (Week 0) was included in the calculation, as this assessment was performed before the first dose was given. The percentage of participants maintaining their mean Hb concentration within +/-1.0 gram/deciliter (g/dL) of their reference Hb and between 10.5 and 12.5 g/dL are reported for efficacy evaluation period (EEP). Efficacy evaluation period was from Week 16 to Week 24 after completion of 16-week dose titration period (DTP).
Outcome measures
| Measure |
C.E.R.A
n=103 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter
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43.7 Percentage of participants
Interval 33.9 to 53.8
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SECONDARY outcome
Timeframe: SVP (Week -4 to -1), EEP (Week 16 to 24)Population: The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.
The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean change in the Hb concentration between the Stability Verification Period (SVP) and the EEP is reported.
Outcome measures
| Measure |
C.E.R.A
n=161 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP
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0.08 g/dL
Standard Deviation 1.48
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SECONDARY outcome
Timeframe: EEP (Week 16 to 24)Population: The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.
The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The percentage of participants maintaining their mean Hb concentration within the target range 10.5 and 12.5 g/dL throughout the EEP are reported.
Outcome measures
| Measure |
C.E.R.A
n=161 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP
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47.8 Percentage of participants
Interval 39.9 to 55.8
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SECONDARY outcome
Timeframe: EEP (Week 16 to 24)Population: The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.
The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean time (days) spent by the participants in the Hb target range 10.5 to 12.5 is reported.
Outcome measures
| Measure |
C.E.R.A
n=161 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP
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30 days
Standard Deviation 19.98
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SECONDARY outcome
Timeframe: EEP (Week 16 to 24)Population: The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.
The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean C.E.R.A dose required to maintain the Hb level within the range 10.5-12.5 g/dL throughout the EEP is presented.
Outcome measures
| Measure |
C.E.R.A
n=161 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP
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139.6 mcg
Standard Deviation 86.58
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SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 24Population: The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.
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 10.5 and 12.5 g/dL throughout the DTP (Week 0 to Week 16) and the EEP (Weeks 16 to 24). The reference Hb value was taken as the mean of all Hb assessments during the stability verification period (Weeks -4, -3, -2, -1). The percentage of participants requiring C.E.R.A dose adjustments during the DTP and EEP are presented.
Outcome measures
| Measure |
C.E.R.A
n=161 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP
Dose adjustment during DTP
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65.8 Percentage of participants
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Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP
Dose adjustment during EEP
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51.1 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 24Population: The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.
The initial dose of C.E.R.A. was 120, 200, or 360 mcg IV or SC every 4 weeks for 48 weeks, which was based on the last dose of the previous ESA. 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 10.5 and 12.5 g/dL throughout the DTP and the EEP. The reference Hb value was taken as the mean of all Hb assessments during the stability verification period. The mean monthly doses of C.E.R.A during the DTP and EEP are presented.
Outcome measures
| Measure |
C.E.R.A
n=161 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Mean Monthly Dose of C.E.R.A During the DTP and EEP
Mean monthly dose during DTP
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142.5 mcg
Standard Deviation 50.32
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Mean Monthly Dose of C.E.R.A During the DTP and EEP
Mean monthly dose during EEP
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139.6 mcg
Standard Deviation 86.58
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SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 44Population: The safety population included all participants who entered into the study.
Red blood cell (RBC) transfusions were permitted during the treatment period in case of medical need. The pre-transfusion Hb level was measured before any transfusion was administered.
Outcome measures
| Measure |
C.E.R.A
n=162 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
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13 participants
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SECONDARY outcome
Timeframe: Up to Week 52Population: The safety population included all participants who entered into the study.
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
Outcome measures
| Measure |
C.E.R.A
n=162 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Number of Participants With Adverse Events and Serious Adverse Events
Participants with AE
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120 participants
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Number of Participants With Adverse Events and Serious Adverse Events
Participants with SAE
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53 participants
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SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48Population: The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.
The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for Hb are as follows: Female: min-max for lower limit=11 to 13 g/dL and min-max for upper limit=14 to 18.1 g/dL; Male: min-max for lower limit=12 to 14.2 g/dL and min-max for upper limit=16 to 18.1 g/dL.
Outcome measures
| Measure |
C.E.R.A
n=162 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Mean Haemoglobin Levels Over Time
Hb at Week 0 (n=162)
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11.4 g/dL
Standard Deviation 0.58
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Mean Haemoglobin Levels Over Time
Hb at Week 8 (n=151)
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11.7 g/dL
Standard Deviation 1.44
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Mean Haemoglobin Levels Over Time
Hb at Week 12 (n=144)
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11.7 g/dL
Standard Deviation 1.67
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Mean Haemoglobin Levels Over Time
Hb at Week 16 (n=141)
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11.6 g/dL
Standard Deviation 1.56
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Mean Haemoglobin Levels Over Time
Hb at Week 20 (n=137)
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11.5 g/dL
Standard Deviation 1.65
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Mean Haemoglobin Levels Over Time
Hb at Week 24 (n=132)
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11.6 g/dL
Standard Deviation 1.36
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Mean Haemoglobin Levels Over Time
Hb at Week 28 (n=121)
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11.8 g/dL
Standard Deviation 1.38
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Mean Haemoglobin Levels Over Time
Hb at Week 32 (n=120)
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11.6 g/dL
Standard Deviation 1.62
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Mean Haemoglobin Levels Over Time
Hb at Week 36 (n= 114)
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11.7 g/dL
Standard Deviation 1.58
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Mean Haemoglobin Levels Over Time
Hb at Week 40 (n=110)
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11.7 g/dL
Standard Deviation 1.31
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Mean Haemoglobin Levels Over Time
Hb at Week 44 (n=105)
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11.5 g/dL
Standard Deviation 1.39
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Mean Haemoglobin Levels Over Time
Hb at Week 48 (n=103)
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11.4 g/dL
Standard Deviation 1.27
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SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48Population: The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.
The haematocrit (HCT) levels in fraction were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for hematocrit are as follows: Female: min-max for lower limit=0.12 - 0.38 and min-max of upper limit=0.43 - 0.537; Male: min-max for lower limit=0.35 - 0.45 and min-max of upper limit=0.45 - 0.54.
Outcome measures
| Measure |
C.E.R.A
n=162 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Mean Hematocrit Levels Over Time
HCT at Week 0 (n=162)
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0.35 Proportion of red blood cells in blood
Standard Deviation 0.02
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Mean Hematocrit Levels Over Time
HCT at Week 8 (n=151)
|
0.35 Proportion of red blood cells in blood
Standard Deviation 0.05
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Mean Hematocrit Levels Over Time
HCT at Week 12 (n=139)
|
0.36 Proportion of red blood cells in blood
Standard Deviation 0.05
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Mean Hematocrit Levels Over Time
HCT at Week 16 (n=141)
|
0.35 Proportion of red blood cells in blood
Standard Deviation 0.05
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Mean Hematocrit Levels Over Time
HCT at Week 20 (n=132)
|
0.35 Proportion of red blood cells in blood
Standard Deviation 0.05
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Mean Hematocrit Levels Over Time
HCT at Week 24 (n=132)
|
0.35 Proportion of red blood cells in blood
Standard Deviation 0.04
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Mean Hematocrit Levels Over Time
HCT at Week 28 (n=117)
|
0.36 Proportion of red blood cells in blood
Standard Deviation 0.04
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Mean Hematocrit Levels Over Time
HCT at Week 32 (n=119)
|
0.36 Proportion of red blood cells in blood
Standard Deviation 0.05
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Mean Hematocrit Levels Over Time
HCT at Week 36 (n=110)
|
0.36 Proportion of red blood cells in blood
Standard Deviation 0.05
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Mean Hematocrit Levels Over Time
HCT at Week 40 (n=110)
|
0.36 Proportion of red blood cells in blood
Standard Deviation 0.04
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Mean Hematocrit Levels Over Time
HCT at Week 44 (n=101)
|
0.35 Proportion of red blood cells in blood
Standard Deviation 0.04
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Mean Hematocrit Levels Over Time
HCT at Week 48 (n=103)
|
0.35 Proportion of red blood cells in blood
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48Population: The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.
The white blood cells (WBC) and thrombocyte levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for WBC are as follows: Female/Male: min-max for lower limit= 3.5 - 5\*10\^9 cells/L and min-max of upper limit= 9 -13.5\*10\^9 cells/L. The standard reference ranges for thrombocyte are as follows: Female/Male: min-max for lower limit= 130 - 150\*10\^9 cells/L and min-max of upper limit= 300 - 450\*10\^9 cells/L.
Outcome measures
| Measure |
C.E.R.A
n=160 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Mean White Blood Cells and Thrombocyte Levels Over Time
WBC at Week 0 (n=160)
|
6.8 10^9 cells/L
Standard Deviation 1.90
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Mean White Blood Cells and Thrombocyte Levels Over Time
WBC at Week 8 (n=147)
|
6.5 10^9 cells/L
Standard Deviation 2.10
|
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Mean White Blood Cells and Thrombocyte Levels Over Time
WBC at Week 16 (n=137)
|
6.7 10^9 cells/L
Standard Deviation 2.01
|
|
Mean White Blood Cells and Thrombocyte Levels Over Time
WBC at Week 24 (n=130)
|
6.6 10^9 cells/L
Standard Deviation 2.09
|
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Mean White Blood Cells and Thrombocyte Levels Over Time
WBC at Week 32 (n=116)
|
6.6 10^9 cells/L
Standard Deviation 1.78
|
|
Mean White Blood Cells and Thrombocyte Levels Over Time
WBC at Week 40 (n=106)
|
6.6 10^9 cells/L
Standard Deviation 2.19
|
|
Mean White Blood Cells and Thrombocyte Levels Over Time
WBC at Week 48 (n=101)
|
6.6 10^9 cells/L
Standard Deviation 1.98
|
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Mean White Blood Cells and Thrombocyte Levels Over Time
Thrombocyte at Week 0 (n=159)
|
219.7 10^9 cells/L
Standard Deviation 59.73
|
|
Mean White Blood Cells and Thrombocyte Levels Over Time
Thrombocyte at Week 8 (n=144)
|
204.4 10^9 cells/L
Standard Deviation 56.21
|
|
Mean White Blood Cells and Thrombocyte Levels Over Time
Thrombocyte at Week 16 (n=135)
|
207.4 10^9 cells/L
Standard Deviation 57.76
|
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Mean White Blood Cells and Thrombocyte Levels Over Time
Thrombocyte at Week 24 (n=129)
|
205.2 10^9 cells/L
Standard Deviation 52.28
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Mean White Blood Cells and Thrombocyte Levels Over Time
Thrombocyte at Week 32 (n=117)
|
207.9 10^9 cells/L
Standard Deviation 69.97
|
|
Mean White Blood Cells and Thrombocyte Levels Over Time
Thrombocyte at Week 40 (n=105)
|
209.3 10^9 cells/L
Standard Deviation 55.95
|
|
Mean White Blood Cells and Thrombocyte Levels Over Time
Thrombocyte at Week 48 (n=101)
|
209.0 10^9 cells/L
Standard Deviation 58.38
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48Population: The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.
The phosphate and potassium levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for phosphate are as follows: Female/Male: min-max for lower limit= 0.48435 - 0.9687 mmol/L and min-max for upper limit=1.45305 - 2.2603 mmol/L. The standard reference ranges for potassium are as follows: Female/Male: min-max for lower limit=3.1 - 3.7 mmol/L and min-max for upper limit=5 - 5.5 mmol/L.
Outcome measures
| Measure |
C.E.R.A
n=159 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
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|---|---|
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Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 0 (n=154)
|
1.61 mmol/L
Standard Deviation 0.55
|
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Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 8 (n=135)
|
1.69 mmol/L
Standard Deviation 0.59
|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 16 (n=131)
|
1.70 mmol/L
Standard Deviation 0.57
|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 24 (n=125)
|
1.68 mmol/L
Standard Deviation 0.57
|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 32 (n=110)
|
1.60 mmol/L
Standard Deviation 0.61
|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 40 (n=105)
|
1.59 mmol/L
Standard Deviation 0.60
|
|
Mean Phosphate and Potassium Levels Over Time
Phosphate at Week 48 (n=97)
|
1.61 mmol/L
Standard Deviation 0.65
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 0 (n=159)
|
4.90 mmol/L
Standard Deviation 0.87
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 8 (n=133)
|
4.80 mmol/L
Standard Deviation 0.86
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 16 (n=133)
|
4.90 mmol/L
Standard Deviation 0.87
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 24 (n=124)
|
4.90 mmol/L
Standard Deviation 0.89
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 32 (n=110)
|
4.80 mmol/L
Standard Deviation 0.83
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 40 (n=104)
|
4.80 mmol/L
Standard Deviation 0.88
|
|
Mean Phosphate and Potassium Levels Over Time
Potassium at Week 48 (n=99)
|
5.00 mmol/L
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48Population: The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.
The creatinine, iron, and total iron binding capacity (TIBC) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for creatinine are as follows: Female: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=79.56 - 123.76 mmol/L; Male: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=97.24 - 123.76 mmol/L. The standard reference ranges for iron are as follows: Female: min-max for lower limit=6.265 - 10.74 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L and Male: min-max for lower limit=6.265 - 11.635 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L. The standard reference ranges for TIBC are as follows: Female: min-max for lower limit=19.69 - 49.046 mmol/L and min-max for upper limit=62.65 - 88.963 mmol/L and Male: min-max for lower limit=19.69 - 52.089 mmol/L and min-max for upper limit=62.65 - 80.55 mmol/L.
Outcome measures
| Measure |
C.E.R.A
n=159 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
|
|---|---|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 0 (n=153)
|
847.1 μmol/L
Standard Deviation 269.15
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 8 (n=120)
|
823.4 μmol/L
Standard Deviation 274.17
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 16 (n=122)
|
814.0 μmol/L
Standard Deviation 268.76
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 24 (n=118)
|
822.9 μmol/L
Standard Deviation 265.76
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 32 (n=112)
|
804.5 μmol/L
Standard Deviation 284.33
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 40 (n=95)
|
809.7 μmol/L
Standard Deviation 292.23
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Creatinine at Week 48 (n=93)
|
816.6 μmol/L
Standard Deviation 315.21
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 0 (n=159)
|
13.9 μmol/L
Standard Deviation 6.28
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 0 (n=97)
|
38.5 μmol/L
Standard Deviation 10.38
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 8 (n=136)
|
16.0 μmol/L
Standard Deviation 6.79
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 16 (n=133)
|
17.6 μmol/L
Standard Deviation 9.79
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 24 (n=121)
|
16.5 μmol/L
Standard Deviation 8.12
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 32 (n=110)
|
16.0 μmol/L
Standard Deviation 8.28
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 40 (n=99)
|
16.3 μmol/L
Standard Deviation 7.75
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Iron at Week 48 (n=97)
|
14.4 μmol/L
Standard Deviation 6.55
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 8 (n=75)
|
39.7 μmol/L
Standard Deviation 11.23
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 16 (n=74)
|
41.5 μmol/L
Standard Deviation 11.99
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 24 (n=76)
|
42.0 μmol/L
Standard Deviation 19.80
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 32 (n=68)
|
41.4 μmol/L
Standard Deviation 11.97
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 40 (n=66)
|
39.6 μmol/L
Standard Deviation 9.31
|
|
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
TIBC at Week 48 (n=58)
|
44.0 μmol/L
Standard Deviation 23.57
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48Population: The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.
Transferrin saturation (TSAT) is the ratio of serum iron and total iron-binding capacity. Transferrin is a blood protein that picks up iron absorbed by the intestines and transports it from one location to another. When iron absorption is abnormally high, transferrin proteins become more saturated with iron. An elevated TS value therefore reflects an increase in iron absorption. The TSAT levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. TSAT was calculated automatically in the electronic case report form (eCRF) according to the following formulae: TSAT= (Serum Iron\*100)/(Transferrin\*1.41) or TSAT=(Serum Iron\*100)/TIBC. Calculated data was not provided by laboratory; therefore no reference range is available.
Outcome measures
| Measure |
C.E.R.A
n=135 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
|
|---|---|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 0 (n=135)
|
34.7 Percentage of Transferrin Saturation
Standard Deviation 19.16
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 8 (n=113)
|
39.8 Percentage of Transferrin Saturation
Standard Deviation 19.52
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 16 (n=113)
|
46.3 Percentage of Transferrin Saturation
Standard Deviation 28.26
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 24 (n=108)
|
42.1 Percentage of Transferrin Saturation
Standard Deviation 22.20
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 32 (n=96)
|
39.3 Percentage of Transferrin Saturation
Standard Deviation 24.83
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 40 (n=91)
|
40.2 Percentage of Transferrin Saturation
Standard Deviation 21.85
|
|
Mean Transferrin Saturation Levels Over Time
TSAT at Week 48 (n=84)
|
36.8 Percentage of Transferrin Saturation
Standard Deviation 21.56
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48Population: The safety population included all participants who entered into the study.
The albumin and transferrin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for albumin are as follows: Female/Male: min-max for lower limit=30 - 35 g/L and min-max for upper limit=48 - 55 g/L. The standard reference ranges for transferrin are as follows: Female/Male: min-max for lower limit=1.5 - 2.3 g/L and min-max for upper limit=2.87 - 4.3 g/L.
Outcome measures
| Measure |
C.E.R.A
n=157 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
|
|---|---|
|
Mean Albumin and Transferrin Levels Over Time
Albumin at Week 0 (n=157)
|
39.5 g/L
Standard Deviation 4.61
|
|
Mean Albumin and Transferrin Levels Over Time
Albumin at Week 8 (n=134)
|
39.3 g/L
Standard Deviation 5.10
|
|
Mean Albumin and Transferrin Levels Over Time
Albumin at Week 16 (n=134)
|
39.3 g/L
Standard Deviation 5.96
|
|
Mean Albumin and Transferrin Levels Over Time
Albumin at Week 24 (n=124)
|
39.3 g/L
Standard Deviation 5.40
|
|
Mean Albumin and Transferrin Levels Over Time
Albumin at Week 32 (n=111)
|
39.4 g/L
Standard Deviation 6.24
|
|
Mean Albumin and Transferrin Levels Over Time
Albumin at Week 40 (n=99)
|
39.9 g/L
Standard Deviation 5.25
|
|
Mean Albumin and Transferrin Levels Over Time
Albumin at Week 48 (n=98)
|
39.6 g/L
Standard Deviation 4.96
|
|
Mean Albumin and Transferrin Levels Over Time
Transferrin at Week 0 (n=75)
|
1.82 g/L
Standard Deviation 0.47
|
|
Mean Albumin and Transferrin Levels Over Time
Transferrin at Week 8 (n=57)
|
1.84 g/L
Standard Deviation 0.54
|
|
Mean Albumin and Transferrin Levels Over Time
Transferrin at Week 16 (n=63)
|
1.81 g/L
Standard Deviation 0.54
|
|
Mean Albumin and Transferrin Levels Over Time
Transferrin at Week 24 (n=54)
|
1.90 g/L
Standard Deviation 0.49
|
|
Mean Albumin and Transferrin Levels Over Time
Transferrin at Week 32 (n==44)
|
1.91 g/L
Standard Deviation 0.60
|
|
Mean Albumin and Transferrin Levels Over Time
Transferrin at Week 40 (n=47)
|
1.96 g/L
Standard Deviation 0.59
|
|
Mean Albumin and Transferrin Levels Over Time
Transferrin at Week 48 (n=46)
|
2.96 g/L
Standard Deviation 7.48
|
SECONDARY outcome
Timeframe: Baseline (Week 0), 8, 16, 24, 32, 40, and 48Population: The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.
C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The CRP test is a general test to check for inflammation in the body.The CRP levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for CRP are as follows: Female/Male: min-max for lower limit=0 - 10 mg/L and min-max for upper limit=0.5 - 30 mg/L.
Outcome measures
| Measure |
C.E.R.A
n=113 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
|
|---|---|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 0 (n=113)
|
54.1 mg/L
Standard Deviation 147.89
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 8 (n=102)
|
87.5 mg/L
Standard Deviation 218.41
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 16 (n=107)
|
186.8 mg/L
Standard Deviation 1414.66
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 24 (n=104)
|
64.0 mg/L
Standard Deviation 163.67
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 32 (n=94)
|
53.4 mg/L
Standard Deviation 118.21
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 40 (n=84)
|
250.6 mg/L
Standard Deviation 1890.84
|
|
Mean C-Reactive Protein Levels Over Time
CRP at Week 48 (n=88)
|
61.7 mg/L
Standard Deviation 169.60
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48Population: The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.
Ferritin is a protein found inside cells that stores iron so that the body can use it later. A ferritin test indirectly measures the amount of iron in your blood. The Ferritin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for ferritin are as follows: Female: min-max for lower limit=6 - 50 mcg/L and min-max for upper limit=120 - 400 mcg/L; Male: min-max for lower limit=10 - 50 mcg/L and min-max for upper limit=200 - 400 mcg/L.
Outcome measures
| Measure |
C.E.R.A
n=157 Participants
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
|
|---|---|
|
Mean Ferritin Levels Over Time
Ferritin at Week 0 (n=157)
|
591.8 mcg/L
Standard Deviation 420.67
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 8 (n=134)
|
617.0 mcg/L
Standard Deviation 428.36
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 16 (n=131)
|
598.8 mcg/L
Standard Deviation 408.20
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 24 (n=123)
|
578.5 mcg/L
Standard Deviation 403.87
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 32 (n=110)
|
583.0 mcg/L
Standard Deviation 478.92
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 40 (n=98)
|
591.2 mcg/L
Standard Deviation 457.24
|
|
Mean Ferritin Levels Over Time
Ferritin at Week 48 (n=97)
|
590.3 mcg/L
Standard Deviation 433.97
|
Adverse Events
C.E.R.A
Serious adverse events
| Measure |
C.E.R.A
n=162 participants at risk
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
2/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Cardiac disorders
Angina Pectoris
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Cardiac disorders
Bradycardia
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Cardiac disorders
Cardiac Failure
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Cardiac disorders
Myocardial Infarction
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Eye disorders
Visual Acuity Reduced
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Gastrointestinal disorders
Diverticulum Intestinal Haemorrhagic
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.9%
3/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Gastrointestinal disorders
Haematemesis
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Gastrointestinal disorders
Peritonitis
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
General disorders
Sudden death
|
1.2%
2/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Infections and infestations
Cellulitis
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Infections and infestations
Device Related Infection
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Infections and infestations
Device Related Sepsis
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Infections and infestations
Diabetic Foot Infection
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Infections and infestations
Gastroenteritis
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Infections and infestations
Infection
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Infections and infestations
Muscle Abscess
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Infections and infestations
Pneumonia
|
3.1%
5/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Infections and infestations
Septic Shock
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
3.1%
5/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Injury, poisoning and procedural complications
Vascular Bypass Dysfunction
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Investigations
Haemoglobin Decreased
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic Syndrome
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Stage 0
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Nervous system disorders
Vascular Dementia
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Nervous system disorders
Vascular Headache
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Renal and urinary disorders
Haematuria
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.2%
2/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Surgical and medical procedures
Renal Transplant
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Vascular disorders
Aortic Dissection
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Vascular disorders
Extremity Necrosis
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Vascular disorders
Hypertensive Crisis
|
1.2%
2/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Vascular disorders
Hypotension
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Vascular disorders
Shock Haemorrhagic
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Vascular disorders
Thrombosis
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Vascular disorders
Venous Stenosis
|
0.62%
1/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
Other adverse events
| Measure |
C.E.R.A
n=162 participants at risk
Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
11/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Vascular disorders
Hypertension
|
14.8%
24/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
|
Vascular disorders
Hypotension
|
8.0%
13/162 • Up to Week 52
Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.
|
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