Trial Outcomes & Findings for A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia (NCT NCT01156363)
NCT ID: NCT01156363
Last Updated: 2015-12-03
Results Overview
Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter \[g/dL\]) throughout the treatment period were reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
86 participants
Primary outcome timeframe
Weeks 1 to 32
Results posted on
2015-12-03
Participant Flow
Efficacy results are reported separately for each of the 3 centers involved in the study \[China Medical University Hospital (CMUH); Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH); and Buddhist Tzu Chi General Hospital (BTCH)\] as well as for overall treatment arm, unless otherwise specified.
Participant milestones
| Measure |
Mircera
Participants received Mircera (epoetin beta-methoxy polyethylene glycol) 80, 120, 200, or 360 micrograms (mcg) (based on the weekly dose of erythropoiesis stimulating agent \[ESA\] participant received in the week preceding the switch to Mircera \[Week -1\]) by intravenous (IV) or subcutaneous (SC) injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on hemoglobin (Hb) level.
This arm includes participants enrolled at all 3 centers.
|
|---|---|
|
Overall Study
STARTED
|
86
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Mircera
Participants received Mircera (epoetin beta-methoxy polyethylene glycol) 80, 120, 200, or 360 micrograms (mcg) (based on the weekly dose of erythropoiesis stimulating agent \[ESA\] participant received in the week preceding the switch to Mircera \[Week -1\]) by intravenous (IV) or subcutaneous (SC) injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on hemoglobin (Hb) level.
This arm includes participants enrolled at all 3 centers.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Insufficient Therapeutic Response
|
5
|
|
Overall Study
Failure to Return
|
1
|
|
Overall Study
Refused Treatment
|
4
|
|
Overall Study
Other
|
6
|
Baseline Characteristics
A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia
Baseline characteristics by cohort
| Measure |
Mircera
n=83 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers.
|
|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 1 to 32Population: ITT Population.
Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter \[g/dL\]) throughout the treatment period were reported.
Outcome measures
| Measure |
Mircera - CMUH
n=35 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at China Medical University Hospital (CMUH).
|
Mircera - KMUH
n=26 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH).
|
Mircera - BTCH
n=22 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH).
|
Mircera
n=83 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers.
|
|---|---|---|---|---|
|
Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range
|
77.1 percentage of participants
|
88.5 percentage of participants
|
90.9 percentage of participants
|
84.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8Population: ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.
The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).
Outcome measures
| Measure |
Mircera - CMUH
n=35 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at China Medical University Hospital (CMUH).
|
Mircera - KMUH
n=26 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH).
|
Mircera - BTCH
n=22 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH).
|
Mircera
n=83 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers.
|
|---|---|---|---|---|
|
Mean Monthly Hb Values
Month 8 (n=26,19,19,64)
|
11.5 g/dL
Standard Deviation 1.0
|
10.8 g/dL
Standard Deviation 0.9
|
11.1 g/dL
Standard Deviation 1.0
|
11.2 g/dL
Standard Deviation 1.0
|
|
Mean Monthly Hb Values
Baseline (n=35,26,22,83)
|
10.7 g/dL
Standard Deviation 0.6
|
11.1 g/dL
Standard Deviation 0.6
|
10.8 g/dL
Standard Deviation 0.4
|
10.8 g/dL
Standard Deviation 0.6
|
|
Mean Monthly Hb Values
Month 1 (n=35,26,22,83)
|
10.7 g/dL
Standard Deviation 1.2
|
11.3 g/dL
Standard Deviation 0.8
|
10.9 g/dL
Standard Deviation 1.0
|
10.9 g/dL
Standard Deviation 1.0
|
|
Mean Monthly Hb Values
Month 2 (n=34,26,21,81)
|
10.8 g/dL
Standard Deviation 1.4
|
10.9 g/dL
Standard Deviation 1.1
|
11.2 g/dL
Standard Deviation 1.2
|
10.9 g/dL
Standard Deviation 1.3
|
|
Mean Monthly Hb Values
Month 3 (n=33,22,20,75)
|
10.8 g/dL
Standard Deviation 1.2
|
10.9 g/dL
Standard Deviation 1.0
|
11.8 g/dL
Standard Deviation 1.0
|
11.1 g/dL
Standard Deviation 1.1
|
|
Mean Monthly Hb Values
Month 4 (n=31,22,19,72)
|
10.9 g/dL
Standard Deviation 1.3
|
10.5 g/dL
Standard Deviation 1.3
|
11.4 g/dL
Standard Deviation 0.9
|
10.9 g/dL
Standard Deviation 1.3
|
|
Mean Monthly Hb Values
Month 5 (n=28,21,19,68)
|
11.0 g/dL
Standard Deviation 1.1
|
10.5 g/dL
Standard Deviation 1.2
|
11.5 g/dL
Standard Deviation 0.9
|
11.0 g/dL
Standard Deviation 1.1
|
|
Mean Monthly Hb Values
Month 6 (n=28,20,19,67)
|
10.9 g/dL
Standard Deviation 1.0
|
10.4 g/dL
Standard Deviation 1.2
|
11.4 g/dL
Standard Deviation 0.9
|
10.9 g/dL
Standard Deviation 1.1
|
|
Mean Monthly Hb Values
Month 7 (n=27,20,19,66)
|
11.3 g/dL
Standard Deviation 0.9
|
10.9 g/dL
Standard Deviation 1.5
|
11.0 g/dL
Standard Deviation 0.9
|
11.1 g/dL
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8Population: ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.
The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).
Outcome measures
| Measure |
Mircera - CMUH
n=35 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at China Medical University Hospital (CMUH).
|
Mircera - KMUH
n=26 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH).
|
Mircera - BTCH
n=22 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH).
|
Mircera
n=83 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers.
|
|---|---|---|---|---|
|
Change in Hb Concentration Between Reference and Treatment Period
Change at Month 1 (n=35,26,22,83)
|
-0.0 g/dL
Standard Deviation 1.0
|
0.1 g/dL
Standard Deviation 0.8
|
0.1 g/dL
Standard Deviation 1.0
|
0.1 g/dL
Standard Deviation 0.9
|
|
Change in Hb Concentration Between Reference and Treatment Period
Change at Month 2 (n=34,26,21,81)
|
0.1 g/dL
Standard Deviation 1.3
|
-0.3 g/dL
Standard Deviation 1.1
|
0.4 g/dL
Standard Deviation 1.3
|
0.0 g/dL
Standard Deviation 1.3
|
|
Change in Hb Concentration Between Reference and Treatment Period
Change at Month 3 (n=33,22,20,75)
|
0.2 g/dL
Standard Deviation 1.1
|
-0.3 g/dL
Standard Deviation 1.2
|
1.0 g/dL
Standard Deviation 1.1
|
0.2 g/dL
Standard Deviation 1.2
|
|
Change in Hb Concentration Between Reference and Treatment Period
Change at Month 4 (n=31,22,19,72)
|
0.2 g/dL
Standard Deviation 1.4
|
-0.7 g/dL
Standard Deviation 1.4
|
0.6 g/dL
Standard Deviation 1.1
|
0.0 g/dL
Standard Deviation 1.4
|
|
Change in Hb Concentration Between Reference and Treatment Period
Change at Month 5 (n=28,21,19,68)
|
0.4 g/dL
Standard Deviation 1.1
|
-0.7 g/dL
Standard Deviation 1.2
|
0.7 g/dL
Standard Deviation 1.0
|
0.1 g/dL
Standard Deviation 1.3
|
|
Change in Hb Concentration Between Reference and Treatment Period
Change at Month 6 (n=28,20,19,67)
|
0.3 g/dL
Standard Deviation 1.2
|
-0.8 g/dL
Standard Deviation 1.2
|
0.6 g/dL
Standard Deviation 1.0
|
0.0 g/dL
Standard Deviation 1.3
|
|
Change in Hb Concentration Between Reference and Treatment Period
Change at Month 7 (n=27,20,19,66)
|
0.7 g/dL
Standard Deviation 1.2
|
-0.4 g/dL
Standard Deviation 1.6
|
0.2 g/dL
Standard Deviation 1.0
|
0.2 g/dL
Standard Deviation 1.3
|
|
Change in Hb Concentration Between Reference and Treatment Period
Change at Month 8 (n=26,19,19,64)
|
0.9 g/dL
Standard Deviation 1.3
|
-0.4 g/dL
Standard Deviation 0.9
|
0.4 g/dL
Standard Deviation 1.2
|
0.4 g/dL
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Weeks 1 to 32Population: ITT Population.
Target Hb concentration was between 10.0 and 12.0 g/dL.
Outcome measures
| Measure |
Mircera - CMUH
n=35 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at China Medical University Hospital (CMUH).
|
Mircera - KMUH
n=26 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH).
|
Mircera - BTCH
n=22 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH).
|
Mircera
n=83 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers.
|
|---|---|---|---|---|
|
Mean Time Participants Spent Having Hb Concentration Within Target Range
|
112.6 days
Standard Deviation 75.6
|
105.0 days
Standard Deviation 74.0
|
107.6 days
Standard Deviation 56.7
|
108.9 days
Standard Deviation 69.8
|
SECONDARY outcome
Timeframe: Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8Population: ITT population. Here, number of participants analyzed signifies participants who were evaluable for this outcome and n signifies participants who were evaluable for specified time-point.
Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm.
Outcome measures
| Measure |
Mircera - CMUH
n=81 Participants
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at China Medical University Hospital (CMUH).
|
Mircera - KMUH
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH).
|
Mircera - BTCH
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH).
|
Mircera
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers.
|
|---|---|---|---|---|
|
Percentage of Participants Requiring Dose Adjustments
Baseline to Month 1: Increase (n=81)
|
7.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Baseline to Month 1: No Change (n=81)
|
61.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Baseline to Month 1: Decrease (n=81)
|
21.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Baseline to Month 1: Not Done (n=81)
|
9.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Month 1 to Month 2: Increase (n=75)
|
4.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Month 1 to Month 2: No Change (n=75)
|
69.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Month 1 to Month 2: Decrease (n=75)
|
16.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Month 1 to Month 2: Not Done (n=75)
|
10.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 2 to 3: Increase (n=72)
|
6.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 2 to 3: No Change (n=72)
|
59.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 2 to 3: Decrease (n=72)
|
19.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 2 to 3: Not Done (n=72)
|
13.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 3 to 4: Increase (n=68)
|
4.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 3 to 4: No Change (n=68)
|
64.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 3 to 4: Decrease (n=68)
|
16.2 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 3 to 4: Not Done (n=68)
|
14.7 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 4 to 5: Increase (n=67)
|
11.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 4 to 5: No Change (n=67)
|
61.2 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 4 to 5: Decrease (n=67)
|
11.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 4 to 5: Not Done (n=67)
|
14.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 5 to 6: Increase (n=66)
|
6.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 5 to 6: No Change (n=66)
|
59.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 5 to 6: Decrease (n=66)
|
21.2 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 5 to 6: Not Done (n=66)
|
13.6 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 6 to 7: Increase (n=64)
|
12.5 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 6 to 7: No Change (n=64)
|
65.6 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 6 to 7: Decrease (n=64)
|
9.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 6 to 7: Not Done (n=64)
|
12.5 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 7 to 8: Increase (n=64)
|
3.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 7 to 8: No Change (n=64)
|
84.4 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 7 to 8: Decrease (n=64)
|
0.0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants Requiring Dose Adjustments
Months 7 to 8: Not Done (n=64)
|
12.5 percentage of participants
|
—
|
—
|
—
|
Adverse Events
Mircera
Serious events: 14 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mircera
n=86 participants at risk
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
General disorders
Pyrexia
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Hepatobiliary disorders
Chronic hepatitis
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Infections and infestations
Abdominal infection
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Infections and infestations
Bacteraemia
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Infections and infestations
Bronchopneumonia
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Infections and infestations
Pharyngitis
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Infections and infestations
Septic embolus
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Infections and infestations
Septic shock
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
2/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Vascular disorders
Labile blood pressure
|
1.2%
1/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
Other adverse events
| Measure |
Mircera
n=86 participants at risk
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera \[Week -1\]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.
This arm includes participants enrolled at all 3 centers.
|
|---|---|
|
Endocrine disorders
Hyperparathyroidism
|
9.3%
8/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.8%
5/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.3%
14/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Gastrointestinal disorders
Constipation
|
18.6%
16/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
11/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Gastrointestinal disorders
Regurgitation
|
7.0%
6/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
General disorders
Oedema peripheral
|
14.0%
12/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
General disorders
Pyrexia
|
5.8%
5/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
9/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
26.7%
23/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Infections and infestations
Urinary tract infection
|
8.1%
7/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.8%
5/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Injury, poisoning and procedural complications
Haemodialysis complication
|
8.1%
7/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
5.8%
5/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
14.0%
12/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Injury, poisoning and procedural complications
Wound
|
5.8%
5/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
15.1%
13/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
15.1%
13/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.8%
11/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Nervous system disorders
Dizziness
|
11.6%
10/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Nervous system disorders
Headache
|
16.3%
14/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Psychiatric disorders
Insomnia
|
14.0%
12/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.9%
24/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.5%
9/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.5%
9/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.8%
11/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.8%
5/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.3%
14/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Vascular disorders
Hypertension
|
32.6%
28/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
|
Vascular disorders
Hypotension
|
7.0%
6/86 • 8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
|
Additional Information
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