Trial Outcomes & Findings for A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia. (NCT NCT00737464)
NCT ID: NCT00737464
Last Updated: 2017-12-07
Results Overview
Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not \>12.0 g/dL and not \<10.0 g/dL.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
132 participants
Primary outcome timeframe
Weeks 8 to 12 (Last 4 weeks of treatment period)
Results posted on
2017-12-07
Participant Flow
A total of 132 participants were enrolled from 26 August 2008 to 12 September 2009 at 11 study sites in India.
Participant milestones
| Measure |
Mircera
Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
132
|
|
Overall Study
COMPLETED
|
114
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Mircera
Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
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|---|---|
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Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
6
|
|
Overall Study
Other - Failure to Return
|
1
|
|
Overall Study
Refused Treatment / Withdrew Consent
|
6
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Overall Study
Other reasons
|
4
|
Baseline Characteristics
A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Baseline characteristics by cohort
| Measure |
Mircera
n=132 Participants
Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
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|---|---|
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Age, Continuous
|
52.74 years
STANDARD_DEVIATION 12.40 • n=5 Participants
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|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
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Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 8 to 12 (Last 4 weeks of treatment period)Population: Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.
Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not \>12.0 g/dL and not \<10.0 g/dL.
Outcome measures
| Measure |
Mircera
n=114 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
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|---|---|
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Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
|
57.89 Percentage of participants
Interval 48.29 to 67.08
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SECONDARY outcome
Timeframe: SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)Population: Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.
The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not \>12.0 g/dL and not \<10.0 g/dL.
Outcome measures
| Measure |
Mircera
n=114 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
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|---|---|
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Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)
Hb in SVP
|
10.76 gm/dL
Standard Deviation 0.75
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|
Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)
Avg of Hb in Last 4 Weeks TP
|
11.28 gm/dL
Standard Deviation 1.22
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SECONDARY outcome
Timeframe: Up to Week 12Population: Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.
Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not \>12.0 g/dL and not \<10.0 g/dL.
Outcome measures
| Measure |
Mircera
n=114 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL
|
3.15 Weeks
Standard Deviation 1.00
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SECONDARY outcome
Timeframe: Up to Week 14Population: Safety population included all enrolled participants who received at least one dose of study drug.
Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. 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.
Outcome measures
| Measure |
Mircera
n=132 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
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|---|---|
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Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths
TEAEs
|
27 Number of participants
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Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths
SAEs
|
9 Number of participants
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Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths
Deaths
|
3 Number of participants
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SECONDARY outcome
Timeframe: From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.
Outcome measures
| Measure |
Mircera
n=132 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Change From Baseline in Heart Rate Over Time
Heart rate, Week -1, (n = 132)
|
78.79 Beats per minute (bpm)
Standard Deviation 7.12
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|
Mean Change From Baseline in Heart Rate Over Time
Heart rate, Week 0, (n = 131)
|
79.54 Beats per minute (bpm)
Standard Deviation 7.27
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|
Mean Change From Baseline in Heart Rate Over Time
Heart rate, Week 1, (n = 129)
|
78.64 Beats per minute (bpm)
Standard Deviation 6.92
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|
Mean Change From Baseline in Heart Rate Over Time
Heart rate, Week 2, (n = 124)
|
78.98 Beats per minute (bpm)
Standard Deviation 7.83
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|
Mean Change From Baseline in Heart Rate Over Time
Heart rate, Week 4, (n = 124)
|
78.61 Beats per minute (bpm)
Standard Deviation 6.92
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|
Mean Change From Baseline in Heart Rate Over Time
Heart rate, Week 6, (n = 121)
|
79.55 Beats per minute (bpm)
Standard Deviation 8.37
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|
Mean Change From Baseline in Heart Rate Over Time
Heart rate, Week 8, (n = 118)
|
79.83 Beats per minute (bpm)
Standard Deviation 7.55
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|
Mean Change From Baseline in Heart Rate Over Time
Heart rate, Week 10, (n = 115)
|
79.56 Beats per minute (bpm)
Standard Deviation 7.54
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|
Mean Change From Baseline in Heart Rate Over Time
Heart rate, Week 12, (n = 115)
|
79.80 Beats per minute (bpm)
Standard Deviation 7.65
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SECONDARY outcome
Timeframe: From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.
Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.
Outcome measures
| Measure |
Mircera
n=132 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
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|---|---|
|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week-2, Before Dialysis (n = 132)
|
145.04 mmHg
Standard Deviation 15.71
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week-2, After Dialysis (n = 131)
|
145.51 mmHg
Standard Deviation 18.12
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week-1, Before Dialysis (n = 132)
|
146.72 mmHg
Standard Deviation 14.77
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week-1, After Dialysis (n =131)
|
143.26 mmHg
Standard Deviation 18.72
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 0, Before Dialysis (n = 131)
|
145.05 mmHg
Standard Deviation 16.04
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 0, After Dialysis (n = 130)
|
143.75 mmHg
Standard Deviation 16.96
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 1, Before Dialysis (n = 129)
|
147.02 mmHg
Standard Deviation 17.40
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 1, After Dialysis (n = 128)
|
144.02 mmHg
Standard Deviation 17.68
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 2, Before Dialysis (n = 124)
|
146.85 mmHg
Standard Deviation 18.08
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 2, After Dialysis (n = 123)
|
144.92 mmHg
Standard Deviation 18.44
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 4, Before Dialysis (n = 124)
|
146.68 mmHg
Standard Deviation 16.98
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 4, After Dialysis (n = 124)
|
143.65 mmHg
Standard Deviation 18.18
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 6, Before Dialysis (n = 121)
|
145.16 mmHg
Standard Deviation 18.58
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 6, After Dialysis (n = 121)
|
145.55 mmHg
Standard Deviation 20.64
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 8, Before Dialysis (n = 118)
|
144.77 mmHg
Standard Deviation 18.84
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 8, After Dialysis (n = 118)
|
143.42 mmHg
Standard Deviation 17.14
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 10, Before Dialysis (n = 115)
|
144.14 mmHg
Standard Deviation 17.57
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 10, After Dialysis (n = 115)
|
143.98 mmHg
Standard Deviation 17.44
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 12, Before Dialysis (n = 115)
|
144.55 mmHg
Standard Deviation 18.46
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
SBP, Week 12, After Dialysis (n = 115)
|
143.80 mmHg
Standard Deviation 18.22
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week -2, Before Dialysis (n = 132)
|
82.92 mmHg
Standard Deviation 9.32
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week -2, After Dialysis (n = 131)
|
84.05 mmHg
Standard Deviation 9.40
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week -1, Before Dialysis (n = 132)
|
83.90 mmHg
Standard Deviation 9.80
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week -1, After Dialysis (n = 131)
|
83.22 mmHg
Standard Deviation 9.51
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 0, Before Dialysis (n = 131)
|
84.05 mmHg
Standard Deviation 8.57
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 0, After Dialysis (n = 130)
|
84.04 mmHg
Standard Deviation 8.94
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 1, Before Dialysis (n = 129)
|
84.68 mmHg
Standard Deviation 9.34
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 1, After Dialysis (n = 128)
|
83.27 mmHg
Standard Deviation 8.97
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 2, Before Dialysis (n = 124)
|
83.77 mmHg
Standard Deviation 8.62
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 2, After Dialysis (n = 123)
|
83.69 mmHg
Standard Deviation 8.85
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 4, Before Dialysis (n = 124)
|
84.15 mmHg
Standard Deviation 8.98
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 4, After Dialysis (n = 124)
|
83.29 mmHg
Standard Deviation 9.27
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 6, Before Dialysis (n = 121)
|
83.31 mmHg
Standard Deviation 8.98
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 6, After Dialysis (n = 121)
|
83.97 mmHg
Standard Deviation 9.24
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 8, Before Dialysis (n = 118)
|
83.28 mmHg
Standard Deviation 9.49
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Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 8, After Dialysis (n = 118)
|
84.35 mmHg
Standard Deviation 8.03
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|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 10, Before Dialysis (n = 115)
|
83.91 mmHg
Standard Deviation 8.55
|
|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 10, After Dialysis (n = 115)
|
84.33 mmHg
Standard Deviation 9.24
|
|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 12, Before Dialysis (n = 115)
|
84.17 mmHg
Standard Deviation 10.47
|
|
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
DBP, Week 12, After Dialysis (n = 115)
|
83.23 mmHg
Standard Deviation 9.45
|
SECONDARY outcome
Timeframe: At Week -2 and Week 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.
Participants with abnormal electrocardiogram were reported.
Outcome measures
| Measure |
Mircera
n=132 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Number of Participants With Abnormal Electrocardiogram
Week -2 (n=132)
|
61 Number of participants
|
|
Number of Participants With Abnormal Electrocardiogram
Week 12 (n=115)
|
50 Number of participants
|
SECONDARY outcome
Timeframe: At Weeks -2, 4, 8, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.
Outcome measures
| Measure |
Mircera
n=132 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Values of White Blood Cells and Platelets Over Time
WBCs, Week -2 (n = 132)
|
7527.50 Per cubic millimeter
Standard Deviation 2444.43
|
|
Mean Values of White Blood Cells and Platelets Over Time
WBCs, Week 4 (n = 114)
|
7369.74 Per cubic millimeter
Standard Deviation 2470.21
|
|
Mean Values of White Blood Cells and Platelets Over Time
WBCs, Week 8 (n = 118)
|
7506.61 Per cubic millimeter
Standard Deviation 2214.38
|
|
Mean Values of White Blood Cells and Platelets Over Time
WBCs, Week 12 (n = 115)
|
7484.35 Per cubic millimeter
Standard Deviation 2130.22
|
|
Mean Values of White Blood Cells and Platelets Over Time
Platelets, Week -2 (n = 132)
|
211772.73 Per cubic millimeter
Standard Deviation 73360.93
|
|
Mean Values of White Blood Cells and Platelets Over Time
Platelets, Week 4 (n = 114)
|
199508.77 Per cubic millimeter
Standard Deviation 64724.91
|
|
Mean Values of White Blood Cells and Platelets Over Time
Platelets, Week 8 (n = 118)
|
208745.76 Per cubic millimeter
Standard Deviation 67546.15
|
|
Mean Values of White Blood Cells and Platelets Over Time
Platelets, Week 12 (n = 115)
|
208566.37 Per cubic millimeter
Standard Deviation 102269.07
|
SECONDARY outcome
Timeframe: At Weeks -2, 4, 8, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.
Outcome measures
| Measure |
Mircera
n=42 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
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Mean Values of Hypochromic Red Blood Cells Over Time
Hypochromic RBCs, Week -2 (n = 41)
|
3.58 Percentage of RBCs
Standard Deviation 0.43
|
|
Mean Values of Hypochromic Red Blood Cells Over Time
Hypochromic RBCs, Week 4 (n = 34)
|
3.73 Percentage of RBCs
Standard Deviation 0.57
|
|
Mean Values of Hypochromic Red Blood Cells Over Time
Hypochromic RBCs, Week 8 (n = 42)
|
3.88 Percentage of RBCs
Standard Deviation 0.59
|
|
Mean Values of Hypochromic Red Blood Cells Over Time
Hypochromic RBCs, Week 12 (n = 42)
|
3.97 Percentage of RBCs
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: At Weeks -2, 4, 8, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.
Outcome measures
| Measure |
Mircera
n=125 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Corpuscular Volume Levels Over Time
MCV, Week -2 (n = 125)
|
90.32 femtoliters
Standard Deviation 7.32
|
|
Mean Corpuscular Volume Levels Over Time
MCV, Week 4 (n = 107)
|
89.99 femtoliters
Standard Deviation 7.53
|
|
Mean Corpuscular Volume Levels Over Time
MCV, Week 8 (n = 112)
|
89.41 femtoliters
Standard Deviation 7.04
|
|
Mean Corpuscular Volume Levels Over Time
MCV, Week 12 (n = 108)
|
88.09 femtoliters
Standard Deviation 8.79
|
SECONDARY outcome
Timeframe: At Weeks -2, 4, 8, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean values of serum iron and total iron binding capacity (TIBC) were reported.
Outcome measures
| Measure |
Mircera
n=131 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
Serum Iron, Week -2 (n = 131)
|
102.13 microgram per deciliter
Standard Deviation 77.47
|
|
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
Serum Iron, Week 4 (n = 122)
|
108.56 microgram per deciliter
Standard Deviation 59.65
|
|
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
Serum Iron, Week 8 (n = 118)
|
116.79 microgram per deciliter
Standard Deviation 67.96
|
|
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
Serum Iron, Week 12 (n = 112)
|
110.53 microgram per deciliter
Standard Deviation 56.31
|
|
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
TIBC, Week -2 (n = 131)
|
273.44 microgram per deciliter
Standard Deviation 114.36
|
|
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
TIBC, Week 4 (n = 122)
|
266.98 microgram per deciliter
Standard Deviation 116.69
|
|
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
TIBC, Week 8 (n = 115)
|
283.50 microgram per deciliter
Standard Deviation 133.49
|
|
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
TIBC, Week 12 (n = 112)
|
276.43 microgram per deciliter
Standard Deviation 118.54
|
SECONDARY outcome
Timeframe: At Weeks -2, 4, 8, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean values of serum ferritin were reported.
Outcome measures
| Measure |
Mircera
n=126 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Values of Serum Ferritin Over Time
Serum Ferritin, Week -2 (n = 126)
|
1806.30 nanogram per mililiter
Standard Deviation 6418.97
|
|
Mean Values of Serum Ferritin Over Time
Serum Ferritin, Week 4 (n = 117)
|
1422.48 nanogram per mililiter
Standard Deviation 2550.43
|
|
Mean Values of Serum Ferritin Over Time
Serum Ferritin, Week 8 (n = 109)
|
1109.07 nanogram per mililiter
Standard Deviation 1050.90
|
|
Mean Values of Serum Ferritin Over Time
Serum Ferritin, Week 12 (n = 105)
|
1109.80 nanogram per mililiter
Standard Deviation 1016.17
|
SECONDARY outcome
Timeframe: At Weeks -2, 4, 8, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean values of transferrin were reported.
Outcome measures
| Measure |
Mircera
n=25 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Values of Transferrin Over Time
Transferrin, Week -2 (n = 25)
|
168.24 miligram per mililiter
Standard Deviation 54.07
|
|
Mean Values of Transferrin Over Time
Transferrin, Week 4 (n = 16)
|
160.00 miligram per mililiter
Standard Deviation 40.04
|
|
Mean Values of Transferrin Over Time
Transferrin, Week 8 (n = 18)
|
165.72 miligram per mililiter
Standard Deviation 40.89
|
|
Mean Values of Transferrin Over Time
Transferrin, Week 12 (n = 18)
|
159.22 miligram per mililiter
Standard Deviation 36.04
|
SECONDARY outcome
Timeframe: At Weeks -2, 4, 8, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean values of Transferrin Saturation (TSAT) were reported.
Outcome measures
| Measure |
Mircera
n=125 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Values of Transferrin Saturation Over Time
TSAT, Week -2 (n = 125)
|
45.55 Percentage
Standard Deviation 38.71
|
|
Mean Values of Transferrin Saturation Over Time
TSAT, Week 4 (n = 116)
|
48.70 Percentage
Standard Deviation 36.31
|
|
Mean Values of Transferrin Saturation Over Time
TSAT, Week 8 (n = 109)
|
46.08 Percentage
Standard Deviation 31.08
|
|
Mean Values of Transferrin Saturation Over Time
TSAT, Week 12 (n = 106)
|
45.71 Percentage
Standard Deviation 29.81
|
SECONDARY outcome
Timeframe: At Weeks -2, 4, 8, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean values of serum albumin and serum globulin were reported.
Outcome measures
| Measure |
Mircera
n=132 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Values of Serum Albumin and Serum Globulin Over Time
Serum Albumin, Week -2 (n = 132)
|
3.60 gram per deciliter
Standard Deviation 0.53
|
|
Mean Values of Serum Albumin and Serum Globulin Over Time
Serum Albumin, Week 4 (n = 123)
|
3.54 gram per deciliter
Standard Deviation 0.42
|
|
Mean Values of Serum Albumin and Serum Globulin Over Time
Serum Albumin, Week 8 (n = 118)
|
3.58 gram per deciliter
Standard Deviation 0.46
|
|
Mean Values of Serum Albumin and Serum Globulin Over Time
Serum Albumin, Week 12 (n = 115)
|
3.64 gram per deciliter
Standard Deviation 0.46
|
|
Mean Values of Serum Albumin and Serum Globulin Over Time
Serum Globulin, Week -2 (n = 131)
|
3.48 gram per deciliter
Standard Deviation 0.65
|
|
Mean Values of Serum Albumin and Serum Globulin Over Time
Serum Globulin, Week 4 (n = 123)
|
3.41 gram per deciliter
Standard Deviation 0.68
|
|
Mean Values of Serum Albumin and Serum Globulin Over Time
Serum Globulin, Week 8 (n = 117)
|
3.55 gram per deciliter
Standard Deviation 0.73
|
|
Mean Values of Serum Albumin and Serum Globulin Over Time
Serum Globulin, Week 12 (n = 113)
|
3.51 gram per deciliter
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: At Weeks -2, 4, 8, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.
Outcome measures
| Measure |
Mircera
n=131 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
AST, Week -2 (n = 128)
|
23.48 units per litre
Standard Deviation 18.45
|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
AST, Week 4 (n = 123)
|
23.26 units per litre
Standard Deviation 12.87
|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
AST, Week 8 (n = 117)
|
22.86 units per litre
Standard Deviation 15.00
|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
AST, Week 12 (n = 115)
|
23.17 units per litre
Standard Deviation 15.69
|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
ALT, Week -2 (n = 129)
|
31.34 units per litre
Standard Deviation 27.52
|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
ALT, Week 4 (n = 121)
|
30.18 units per litre
Standard Deviation 18.82
|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
ALT, Week 8 (n = 118)
|
29.44 units per litre
Standard Deviation 20.26
|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
ALT, Week 12 (n = 115)
|
31.07 units per litre
Standard Deviation 20.71
|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
Serum Alkaline Phosphatase, Week -2 (n = 131)
|
154.7 units per litre
Standard Deviation 110.6
|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
Serum Alkaline Phosphatase, Week 4 (n = 123)
|
163.3 units per litre
Standard Deviation 108.9
|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
Serum Alkaline Phosphatase, Week 8 (n = 118)
|
162.1 units per litre
Standard Deviation 123.4
|
|
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
Serum Alkaline Phosphatase, Week 12 (n = 115)
|
159.3 units per litre
Standard Deviation 100.1
|
SECONDARY outcome
Timeframe: At Weeks -2, 4, 8, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.
Outcome measures
| Measure |
Mircera
n=132 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Creatinine, Week -2 (n = 132)
|
7.89 miligram per deciliter
Standard Deviation 2.96
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Creatinine, Week 4 (n = 123)
|
8.34 miligram per deciliter
Standard Deviation 2.47
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Creatinine, Week 8 (n = 116)
|
8.03 miligram per deciliter
Standard Deviation 2.36
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Creatinine, Week 12 (n = 115)
|
8.19 miligram per deciliter
Standard Deviation 2.72
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
BUN, Week -2 (n = 131)
|
57.72 miligram per deciliter
Standard Deviation 29.71
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
BUN, Week 4 (n = 122)
|
60.67 miligram per deciliter
Standard Deviation 27.70
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
BUN, Week 8 (n = 117)
|
60.10 miligram per deciliter
Standard Deviation 32.04
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
BUN, Week 12 (n = 113)
|
61.79 miligram per deciliter
Standard Deviation 35.14
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Phosphate, Week -2 (n = 124)
|
5.00 miligram per deciliter
Standard Deviation 4.70
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Phosphate, Week 4 (n = 114)
|
5.02 miligram per deciliter
Standard Deviation 1.93
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Phosphate, Week 8 (n = 112)
|
4.81 miligram per deciliter
Standard Deviation 1.64
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Phosphate, Week 12 (n = 107)
|
5.37 miligram per deciliter
Standard Deviation 5.22
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Bilirubin, Week -2 (n = 131)
|
0.52 miligram per deciliter
Standard Deviation 0.34
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Bilirubin, Week 4 (n = 123)
|
0.50 miligram per deciliter
Standard Deviation 0.33
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Bilirubin, Week 8 (n = 118)
|
0.52 miligram per deciliter
Standard Deviation 0.43
|
|
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Serum Bilirubin, Week 12 (n = 115)
|
0.51 miligram per deciliter
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: At Weeks -2, 4, 8, and 12Population: Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.
Mean values of serum sodium and serum potassium were reported.
Outcome measures
| Measure |
Mircera
n=132 Participants
Eligible participants were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Mean Values of Serum Sodium and Serum Potassium Over Time
Serum Potassium, Week -2 (n = 132)
|
5.00 millimole per liter
Standard Deviation 0.94
|
|
Mean Values of Serum Sodium and Serum Potassium Over Time
Serum Potassium, Week 4 (n = 123)
|
6.26 millimole per liter
Standard Deviation 11.74
|
|
Mean Values of Serum Sodium and Serum Potassium Over Time
Serum Potassium, Week 8 (n = 118)
|
5.11 millimole per liter
Standard Deviation 0.88
|
|
Mean Values of Serum Sodium and Serum Potassium Over Time
Serum Potassium, Week 12 (n = 115)
|
5.03 millimole per liter
Standard Deviation 1.08
|
|
Mean Values of Serum Sodium and Serum Potassium Over Time
Serum Sodium, Week -2 (n = 132)
|
137.1 millimole per liter
Standard Deviation 4.36
|
|
Mean Values of Serum Sodium and Serum Potassium Over Time
Serum Sodium, Week 4 (n = 122)
|
136.2 millimole per liter
Standard Deviation 12.65
|
|
Mean Values of Serum Sodium and Serum Potassium Over Time
Serum Sodium, Week 8 (n = 118)
|
137.0 millimole per liter
Standard Deviation 4.58
|
|
Mean Values of Serum Sodium and Serum Potassium Over Time
Serum Sodium, Week 12 (n = 115)
|
136.9 millimole per liter
Standard Deviation 5.37
|
Adverse Events
Mircera
Serious events: 9 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mircera
n=132 participants at risk
Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Arrhythmia
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Peritonitis
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
General disorders
Death
|
2.3%
3/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Coma
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Convulsion
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Azotaemia
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
Mircera
n=132 participants at risk
Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
2/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
4/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
General disorders
Chills
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
3.0%
4/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Abscess
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Injury
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Investigations
Hepatic enzyme increased
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
1.5%
2/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Surgical and medical procedures
Peritoneal dialysis
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.76%
1/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
|
Vascular disorders
Thrombosis
|
2.3%
3/132 • Up to Week 14
SAEs and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study medication.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
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