Trial Outcomes & Findings for A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA. (NCT NCT00661388)
NCT ID: NCT00661388
Last Updated: 2025-09-11
Results Overview
Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP \[Week 29 to Week 36\]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement.
COMPLETED
PHASE3
75 participants
From Baseline (Week 0) to EEP (Week 29 to Week 36)
2025-09-11
Participant Flow
A total of 75 participants were enrolled in this study conducted from 12 August 2008 to December 2010 at 9 centers in Turkey.
Participant milestones
| Measure |
C.E.R.A
Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A) subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 micrograms (mcg)/kilogram (kg). Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) within the target range of 10.0 and 12.0 grams (g)/ deciliter (dL).
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|---|---|
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Overall Study
STARTED
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75
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Overall Study
COMPLETED
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51
|
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Overall Study
NOT COMPLETED
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24
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Reasons for withdrawal
| Measure |
C.E.R.A
Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A) subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 micrograms (mcg)/kilogram (kg). Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) within the target range of 10.0 and 12.0 grams (g)/ deciliter (dL).
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|---|---|
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Overall Study
Adverse Event
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14
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Overall Study
Protocol Violation
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7
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Overall Study
Renal transplantation
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1
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Overall Study
Dialysis initiation
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1
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Overall Study
Administrative reasons
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1
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Baseline Characteristics
A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.
Baseline characteristics by cohort
| Measure |
C.E.R.A
n=75 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Age, Continuous
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52.8 years
STANDARD_DEVIATION 16.36 • n=5 Participants
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Sex: Female, Male
Female
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57 Participants
n=5 Participants
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Sex: Female, Male
Male
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18 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From Baseline (Week 0) to EEP (Week 29 to Week 36)Population: Per protocol (PP) population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.
Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP \[Week 29 to Week 36\]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement.
Outcome measures
| Measure |
C.E.R.A
n=41 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period
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1.99 g/dL
Standard Deviation 0.74
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SECONDARY outcome
Timeframe: From Week 29 to Week 36Population: PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.
Participants with Hb concentrations within target range of 10-12 g/dl were considered to be responders. Mean time to achievement of response during the EEP (Week 29 to Week 36) is presented.
Outcome measures
| Measure |
C.E.R.A
n=41 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Mean Time to Achievement of Response During the EEP
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24.2 Days
Standard Deviation 20.96
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SECONDARY outcome
Timeframe: From Week 29 to Week 36Population: PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up variable were included. Participants with less than three recorded Hb values during EEP; participants missing administration of C.E.R.A. during weeks 28-36; participants with inadequate iron status, were excluded.
The percentage of participants whose Hb Concentrations remained within the target range of 10.0- 12.0 g/dL throughout the EEP (Week 29 to Week 36) is presented.
Outcome measures
| Measure |
C.E.R.A
n=41 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP
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43.9 Percentage of participants
Interval 28.5 to 60.3
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SECONDARY outcome
Timeframe: From Week 29 to Week 36Population: PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.
Mean time spent by participants in the target range of 10.0- 12.0 g/dL during the EEP (Week 29 to Week 36) is presented.
Outcome measures
| Measure |
C.E.R.A
n=41 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP
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40.6 Days
Standard Deviation 16.31
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SECONDARY outcome
Timeframe: Weeks 0 to Week 36Population: PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.
Percentage of participants requiring dose adjustments during dose titration period (DTP \[Week 0 to Week 28\]) and EEP (Week 29 to Week 36) is presented. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either ≥ 13 g/dL or \< 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥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 to 12 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 10.5 to 11.5 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=41 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
Any dose adjustment in DTP
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85.4 Percentage of participants
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Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
Dose increased in DTP
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14.6 Percentage of participants
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Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
Dose decreased in DTP
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24.4 Percentage of participants
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Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
Dose increased and decreased in DTP
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46.3 Percentage of participants
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Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
Any dose adjustment in EEP
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56.1 Percentage of participants
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Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
Dose increased in EEP
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17.1 Percentage of participants
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Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
Dose decreased in EEP
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31.7 Percentage of participants
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Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP
Dose increased and decreased in EEP
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7.3 Percentage of participants
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SECONDARY outcome
Timeframe: Up to Week 52Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants who entered a particular phase is determined by 'n'.
Red blood cell transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP (Week 0 to Week 28), EEP (Week 29 to Week 36), and during the long term safety period (LSTP \[Week 37 to Week 52\]) are presented.
Outcome measures
| Measure |
C.E.R.A
n=75 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Number of Participants Who Received Red Blood Cell Transfusions During the Study Period
DTP (n = 75)
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2 Number of participants
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Number of Participants Who Received Red Blood Cell Transfusions During the Study Period
EEP (n = 57)
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1 Number of participants
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Number of Participants Who Received Red Blood Cell Transfusions During the Study Period
LSTP (n = 54)
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1 Number of participants
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SECONDARY outcome
Timeframe: Up to Week 52Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Outcome measures
| Measure |
C.E.R.A
n=75 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
Any AEs
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58 Participants
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Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
Any SAEs
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24 Participants
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SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.
Mean change from Baseline in Hb concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A
n=70 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Mean Change From Baseline in Hb Concentration Over Time
Week 8 (n = 70)
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1.50 g/dL
Standard Deviation 0.96
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Mean Change From Baseline in Hb Concentration Over Time
Week 16 (n = 62)
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2.03 g/dL
Standard Deviation 1.16
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Mean Change From Baseline in Hb Concentration Over Time
Week 24 (n = 59)
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1.86 g/dL
Standard Deviation 1.01
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Mean Change From Baseline in Hb Concentration Over Time
Week 32 (n = 55)
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1.85 g/dL
Standard Deviation 0.84
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Mean Change From Baseline in Hb Concentration Over Time
Week 40 (n = 52)
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1.84 g/dL
Standard Deviation 1.06
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Mean Change From Baseline in Hb Concentration Over Time
Week 48 (n = 48)
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1.59 g/dL
Standard Deviation 0.81
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SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.
Mean change from Baseline in hematocrit level was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A
n=70 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Mean Change From Baseline in Hematocrit Level Over Time
Week 8 (n = 70)
|
0.05 Fraction
Standard Deviation 0.03
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Mean Change From Baseline in Hematocrit Level Over Time
Week 16 (n = 62)
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0.06 Fraction
Standard Deviation 0.04
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Mean Change From Baseline in Hematocrit Level Over Time
Week 24 (n = 59)
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0.06 Fraction
Standard Deviation 0.03
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Mean Change From Baseline in Hematocrit Level Over Time
Week 32 (n = 55)
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0.06 Fraction
Standard Deviation 0.03
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Mean Change From Baseline in Hematocrit Level Over Time
Week 40 (n = 51)
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0.06 Fraction
Standard Deviation 0.03
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Mean Change From Baseline in Hematocrit Level Over Time
Week 48 (n = 49)
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0.05 Fraction
Standard Deviation 0.02
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SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, and 48Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.
Mean change from Baseline in erythrocyte mean corpuscular volume was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A
n=65 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time
Week 8 (n = 65)
|
0.17 Femtoliters
Standard Deviation 3.20
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Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time
Week 16 (n = 57)
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-1.31 Femtoliters
Standard Deviation 3.70
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Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time
Week 24 (n = 55)
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-1.10 Femtoliters
Standard Deviation 4.40
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Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time
Week 32 (n = 52)
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-0.34 Femtoliters
Standard Deviation 4.62
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Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time
Week 48 (n = 47)
|
0.97 Femtoliters
Standard Deviation 3.67
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SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.
Mean change from Baseline in white blood cells (WBCs) and platelets concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A
n=66 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
WBCs at Week 8 (n = 66)
|
0.04 10^9 cells/Liter (L)
Standard Deviation 1.59
|
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Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
WBCs at Week 16 (n = 58)
|
0.06 10^9 cells/Liter (L)
Standard Deviation 1.36
|
|
Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
WBCs at Week 24 (n = 55)
|
0.12 10^9 cells/Liter (L)
Standard Deviation 1.46
|
|
Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
WBCs at Week 32 (n = 52)
|
0.01 10^9 cells/Liter (L)
Standard Deviation 1.48
|
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Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
WBCs at Week 40 (n = 47)
|
-0.13 10^9 cells/Liter (L)
Standard Deviation 1.54
|
|
Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
WBCs at Week 48 (n = 47)
|
0.04 10^9 cells/Liter (L)
Standard Deviation 1.43
|
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Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
Platelets at Week 8 (n = 66)
|
-8.39 10^9 cells/Liter (L)
Standard Deviation 52.64
|
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Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
Platelets at Week 16 (n = 58)
|
-15.73 10^9 cells/Liter (L)
Standard Deviation 46.37
|
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Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
Platelets at Week 24 (n = 55)
|
-20.55 10^9 cells/Liter (L)
Standard Deviation 41.59
|
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Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
Platelets at Week 32 (n = 52)
|
-25.34 10^9 cells/Liter (L)
Standard Deviation 47.22
|
|
Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
Platelets at Week 40 (n = 47)
|
-25.84 10^9 cells/Liter (L)
Standard Deviation 46.90
|
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Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time
Platelets at Week 48 (n = 47)
|
-23.40 10^9 cells/Liter (L)
Standard Deviation 40.74
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.
Mean change from Baseline in albumin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A
n=62 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
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|---|---|
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Mean Change From Baseline in Albumin Concentration Over Time
Week 8 (n = 62)
|
0.45 g/L
Standard Deviation 3.12
|
|
Mean Change From Baseline in Albumin Concentration Over Time
Week 16 (n = 52)
|
0.06 g/L
Standard Deviation 3.27
|
|
Mean Change From Baseline in Albumin Concentration Over Time
Week 24 (n = 53)
|
-0.30 g/L
Standard Deviation 3.59
|
|
Mean Change From Baseline in Albumin Concentration Over Time
Week 32 (n = 48)
|
0.24 g/L
Standard Deviation 5.37
|
|
Mean Change From Baseline in Albumin Concentration Over Time
Week 40 (n = 45)
|
-0.57 g/L
Standard Deviation 3.34
|
|
Mean Change From Baseline in Albumin Concentration Over Time
Week 48 (n = 46)
|
-0.61 g/L
Standard Deviation 3.82
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.
Mean change from Baseline in C-Reactive Protein concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A
n=55 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
|
|---|---|
|
Mean Change From Baseline in C-Reactive Protein Concentration Over Time
Week 8 (n = 55)
|
-1.82 Milligrams /L
Standard Deviation 13.24
|
|
Mean Change From Baseline in C-Reactive Protein Concentration Over Time
Week 16 (n = 44)
|
-1.80 Milligrams /L
Standard Deviation 13.05
|
|
Mean Change From Baseline in C-Reactive Protein Concentration Over Time
Week 24 (n = 45)
|
0.03 Milligrams /L
Standard Deviation 9.31
|
|
Mean Change From Baseline in C-Reactive Protein Concentration Over Time
Week 32 (n = 38)
|
-0.33 Milligrams /L
Standard Deviation 9.88
|
|
Mean Change From Baseline in C-Reactive Protein Concentration Over Time
Week 40 (n = 42)
|
-1.49 Milligrams /L
Standard Deviation 4.78
|
|
Mean Change From Baseline in C-Reactive Protein Concentration Over Time
Week 48 (n = 39)
|
0.86 Milligrams /L
Standard Deviation 6.57
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.
Mean change from Baseline in phosphate and potassium concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A
n=63 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
|
|---|---|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Phosphate at Week 8 (n = 59)
|
0.11 Millimoles /L
Standard Deviation 0.35
|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Phosphate at Week 16 (n = 48)
|
0.06 Millimoles /L
Standard Deviation 0.26
|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Phosphate at Week 24 (n = 51)
|
0.07 Millimoles /L
Standard Deviation 0.36
|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Phosphate at Week 32 (n = 45)
|
0.13 Millimoles /L
Standard Deviation 0.27
|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Phosphate at Week 40 (n = 44)
|
0.06 Millimoles /L
Standard Deviation 0.31
|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Phosphate at Week 48 (n = 43)
|
0.07 Millimoles /L
Standard Deviation 0.30
|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Potassium at Week 8 (n = 63)
|
0.12 Millimoles /L
Standard Deviation 0.53
|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Potassium at Week 16 (n = 54)
|
0.03 Millimoles /L
Standard Deviation 0.68
|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Potassium at Week 24 (n = 53)
|
0.02 Millimoles /L
Standard Deviation 0.56
|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Potassium at Week 32 (n = 49)
|
-0.04 Millimoles /L
Standard Deviation 0.63
|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Potassium at Week 40 (n = 46)
|
0.16 Millimoles /L
Standard Deviation 0.56
|
|
Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time
Potassium at Week 48 (n = 47)
|
0.03 Millimoles /L
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.
Mean change from Baseline in total iron binding capacity (TIBC) and iron concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A
n=63 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
|
|---|---|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
TIBC at Week 8 (n = 62)
|
0.09 Micromole /L
Standard Deviation 10.02
|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
TIBC at Week 16 (n = 53)
|
-0.21 Micromole /L
Standard Deviation 8.12
|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
TIBC at Week 24 (n = 52)
|
0.34 Micromole /L
Standard Deviation 10.78
|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
TIBC at Week 32 (n = 47)
|
0.15 Micromole /L
Standard Deviation 10.53
|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
TIBC at Week 40 (n = 45)
|
2.24 Micromole /L
Standard Deviation 19.75
|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
TIBC at Week 48 (n = 46)
|
-2.02 Micromole /L
Standard Deviation 11.05
|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
Iron at Week 8 (n = 63)
|
-1.93 Micromole /L
Standard Deviation 7.31
|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
Iron at Week 16 (n = 53)
|
0.31 Micromole /L
Standard Deviation 6.79
|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
Iron at Week 24 (n = 54)
|
0.55 Micromole /L
Standard Deviation 8.56
|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
Iron at Week 32 (n = 47)
|
0.68 Micromole /L
Standard Deviation 8.64
|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
Iron at Week 40 (n = 45)
|
1.64 Micromole /L
Standard Deviation 6.76
|
|
Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time
Iron at Week 48 (n = 46)
|
0.80 Micromole /L
Standard Deviation 9.24
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 8, 16, 32, 40Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.
Mean change from Baseline in creatinine concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A
n=4 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
|
|---|---|
|
Mean Change From Baseline in Creatinine Concentration Over Time
Week 8 (n = 4)
|
23.87 Micromole/L
Interval -24.8 to 44.2
|
|
Mean Change From Baseline in Creatinine Concentration Over Time
Week 16 (n = 2)
|
123.67 Micromole/L
Interval 53.0 to 194.5
|
|
Mean Change From Baseline in Creatinine Concentration Over Time
Week 32 (n = 2)
|
-8.40 Micromole/L
Interval -17.7 to 0.9
|
|
Mean Change From Baseline in Creatinine Concentration Over Time
Week 40 (n = 1)
|
17.7 Micromole/L
Interval 17.7 to 17.7
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.
Mean change from Baseline in ferritin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A
n=52 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
|
|---|---|
|
Mean Change From Baseline in Ferritin Concentration Over Time
Ferritin at Week 8 (n = 52)
|
-95.15 mcg/L
Standard Deviation 86.09
|
|
Mean Change From Baseline in Ferritin Concentration Over Time
Ferritin at Week 16 (n = 49)
|
-82.82 mcg/L
Standard Deviation 115.68
|
|
Mean Change From Baseline in Ferritin Concentration Over Time
Ferritin at Week 24 (n = 42)
|
-71.98 mcg/L
Standard Deviation 131.47
|
|
Mean Change From Baseline in Ferritin Concentration Over Time
Ferritin at Week 32 (n = 39)
|
-78.45 mcg/L
Standard Deviation 121.12
|
|
Mean Change From Baseline in Ferritin Concentration Over Time
Ferritin at Week 40 (n = 42)
|
-59.94 mcg/L
Standard Deviation 141.89
|
|
Mean Change From Baseline in Ferritin Concentration Over Time
Ferritin at Week 48 (n = 43)
|
-43.46 mcg/L
Standard Deviation 146.58
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48Population: Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.
Mean change from Baseline in transferrin saturation (TSAT) was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.
Outcome measures
| Measure |
C.E.R.A
n=62 Participants
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
|
|---|---|
|
Mean Change From Baseline in Transferrin Saturation Over Time
TSAT at Week 8 (n = 62)
|
-5.91 Percentage of Transferrin Saturation
Standard Deviation 19.83
|
|
Mean Change From Baseline in Transferrin Saturation Over Time
TSAT at Week 16 (n = 52)
|
1.69 Percentage of Transferrin Saturation
Standard Deviation 13.85
|
|
Mean Change From Baseline in Transferrin Saturation Over Time
TSAT at Week 24 (n = 51)
|
1.42 Percentage of Transferrin Saturation
Standard Deviation 15.15
|
|
Mean Change From Baseline in Transferrin Saturation Over Time
TSAT at Week 32 (n = 47)
|
2.52 Percentage of Transferrin Saturation
Standard Deviation 15.70
|
|
Mean Change From Baseline in Transferrin Saturation Over Time
TSAT at Week 40 (n = 45)
|
3.52 Percentage of Transferrin Saturation
Standard Deviation 13.02
|
|
Mean Change From Baseline in Transferrin Saturation Over Time
TSAT at Week 48 (n = 46)
|
5.32 Percentage of Transferrin Saturation
Standard Deviation 21.60
|
Adverse Events
C.E.R.A
Serious adverse events
| Measure |
C.E.R.A
n=75 participants at risk
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytosis
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Angina pectoris
|
2.7%
2/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
General disorders
Chest pain
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
General disorders
Oedema
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Pyelonephritis acute
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Investigations
Blood creatine increased
|
2.7%
2/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Investigations
Blood creatinine increased
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Investigations
Creatinine renal clearance decreased
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
8.0%
6/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Renal and urinary disorders
Azotaemia
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Renal and urinary disorders
Renal failure
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Surgical and medical procedures
Haemodialysis
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Surgical and medical procedures
Insertion of ambulatory peritoneal catheter
|
1.3%
1/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
Other adverse events
| Measure |
C.E.R.A
n=75 participants at risk
Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
|
|---|---|
|
Vascular disorders
Hypertension
|
20.0%
15/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Constipation
|
9.3%
7/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
6/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.0%
9/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.3%
4/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
6/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
6.7%
5/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Investigations
Blood pressure increased
|
5.3%
4/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
4/75 • Up to Week 52
SAEs and non-serious AEs were reported for the safety population, comprised of participants who received at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
|
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