Anemia
Conditions
Brief summary
This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta \[Mircera\] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is \<200 patients.
Interventions
PROCEDUREDialysis
regular haemodialysis or peritoneal dialysis
DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]
once monthly, subcutaneously or intravenously, for 32 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>/=18 years of age * chronic renal anaemia * haemoglobin 10.0-12.0g/dl at screening * adequate iron status * continuous stable ESA (erythropoietic stimulating agent) therapy for \>/= 2 months * regular haemodialysis or regular peritoneal dialysis for \>/= 3 months
Exclusion criteria
* uncontrolled hypertension * haemoglobinopathy * anaemia due to haemolysis * pure red cell aplasia (PRCA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range | Weeks 1 to 32 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Monthly Hb Values | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 | 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). |
| Change in Hb Concentration Between Reference and Treatment Period | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 | 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). |
| Mean Time Participants Spent Having Hb Concentration Within Target Range | Weeks 1 to 32 | Target Hb concentration was between 10.0 and 12.0 g/dL. |
| Percentage of Participants Requiring Dose Adjustments | 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 8 | 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. |
Countries
Taiwan
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) 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. | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Failure to Return | 1 |
| Overall Study | Insufficient Therapeutic Response | 5 |
| Overall Study | Other | 6 |
| Overall Study | Refused Treatment | 4 |
Baseline characteristics
| Characteristic | Mircera |
|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 13.3 |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 79 / 86 |
| serious Total, serious adverse events | 14 / 86 |
Outcome results
Primary
Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range
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.
Time frame: Weeks 1 to 32
Population: ITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mircera - CMUH | Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range | 77.1 percentage of participants |
| Mircera - KMUH | Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range | 88.5 percentage of participants |
| Mircera - BTCH | Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range | 90.9 percentage of participants |
| Mircera | Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range | 84.3 percentage of participants |
Secondary
Change in Hb Concentration Between Reference and Treatment Period
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).
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8
Population: ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mircera - CMUH | 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 |
| Mircera - CMUH | 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 |
| Mircera - CMUH | 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 |
| Mircera - CMUH | 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 |
| Mircera - CMUH | 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 |
| Mircera - CMUH | 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 |
| Mircera - CMUH | 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 |
| Mircera - CMUH | 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 |
| Mircera - KMUH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 6 (n=28,20,19,67) | -0.8 g/dL | Standard Deviation 1.2 |
| Mircera - KMUH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 5 (n=28,21,19,68) | -0.7 g/dL | Standard Deviation 1.2 |
| Mircera - KMUH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 2 (n=34,26,21,81) | -0.3 g/dL | Standard Deviation 1.1 |
| Mircera - KMUH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 8 (n=26,19,19,64) | -0.4 g/dL | Standard Deviation 0.9 |
| Mircera - KMUH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 7 (n=27,20,19,66) | -0.4 g/dL | Standard Deviation 1.6 |
| Mircera - KMUH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 4 (n=31,22,19,72) | -0.7 g/dL | Standard Deviation 1.4 |
| Mircera - KMUH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 3 (n=33,22,20,75) | -0.3 g/dL | Standard Deviation 1.2 |
| Mircera - KMUH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 1 (n=35,26,22,83) | 0.1 g/dL | Standard Deviation 0.8 |
| Mircera - BTCH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 7 (n=27,20,19,66) | 0.2 g/dL | Standard Deviation 1 |
| Mircera - BTCH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 3 (n=33,22,20,75) | 1.0 g/dL | Standard Deviation 1.1 |
| Mircera - BTCH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 4 (n=31,22,19,72) | 0.6 g/dL | Standard Deviation 1.1 |
| Mircera - BTCH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 5 (n=28,21,19,68) | 0.7 g/dL | Standard Deviation 1 |
| Mircera - BTCH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 6 (n=28,20,19,67) | 0.6 g/dL | Standard Deviation 1 |
| Mircera - BTCH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 8 (n=26,19,19,64) | 0.4 g/dL | Standard Deviation 1.2 |
| Mircera - BTCH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 1 (n=35,26,22,83) | 0.1 g/dL | Standard Deviation 1 |
| Mircera - BTCH | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 2 (n=34,26,21,81) | 0.4 g/dL | Standard Deviation 1.3 |
| Mircera | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 3 (n=33,22,20,75) | 0.2 g/dL | Standard Deviation 1.2 |
| Mircera | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 4 (n=31,22,19,72) | 0.0 g/dL | Standard Deviation 1.4 |
| Mircera | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 2 (n=34,26,21,81) | 0.0 g/dL | Standard Deviation 1.3 |
| Mircera | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 1 (n=35,26,22,83) | 0.1 g/dL | Standard Deviation 0.9 |
| Mircera | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 5 (n=28,21,19,68) | 0.1 g/dL | Standard Deviation 1.3 |
| Mircera | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 8 (n=26,19,19,64) | 0.4 g/dL | Standard Deviation 1.3 |
| Mircera | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 7 (n=27,20,19,66) | 0.2 g/dL | Standard Deviation 1.3 |
| Mircera | Change in Hb Concentration Between Reference and Treatment Period | Change at Month 6 (n=28,20,19,67) | 0.0 g/dL | Standard Deviation 1.3 |
Comparison: Change from baseline to Month 4: analysis was performed using paired t-test.p-value: 0.0209Paired t-test
Comparison: Change from baseline to Month 4: analysis was performed using paired t-test.p-value: 0.8206Paired t-test
Comparison: Change from baseline to Month 5: analysis was performed using paired t-test.p-value: 0.0907Paired t-test
Comparison: Change from baseline to Month 1: analysis was performed using paired t-test.p-value: 0.9825Paired t-test
Comparison: Change from baseline to Month 1: analysis was performed using paired t-test.p-value: 0.5737Paired t-test
Comparison: Change from baseline to Month 1: analysis was performed using paired t-test.p-value: 0.5703Paired t-test
Comparison: Change from baseline to Month 1: analysis was performed using paired t-test.p-value: 0.5684Paired t-test
Comparison: Change from baseline to Month 2: analysis was performed using paired t-test.p-value: 0.8235Paired t-test
Comparison: Change from baseline to Month 2: analysis was performed using paired t-test.p-value: 0.2384Paired t-test
Comparison: Change from baseline to Month 2: analysis was performed using paired t-test.p-value: 0.1634Paired t-test
Comparison: Change from baseline to Month 2: analysis was performed using paired t-test.p-value: 0.7816Paired t-test
Comparison: Change from baseline to Month 3: analysis was performed using paired t-test.p-value: 0.3917Paired t-test
Comparison: Change from baseline to Month 3: analysis was performed using paired t-test.p-value: 0.1749Paired t-test
Comparison: Change from baseline to Month 3: analysis was performed using paired t-test.p-value: <0.001Paired t-test
Comparison: Change from baseline to Month 3: analysis was performed using paired t-test.p-value: 0.0905Paired t-test
Comparison: Change from baseline to Month 4: analysis was performed using paired t-test.p-value: 0.3766Paired t-test
Comparison: Change from baseline to Month 4: analysis was performed using paired t-test.p-value: 0.0253Paired t-test
Comparison: Change from baseline to Month 5: analysis was performed using paired t-test.p-value: 0.0177Paired t-test
Comparison: Change from baseline to Month 5: analysis was performed using paired t-test.p-value: 0.005Paired t-test
Comparison: Change from baseline to Month 5: analysis was performed using paired t-test.p-value: 0.3724Paired t-test
Comparison: Change from baseline to Month 6: analysis was performed using paired t-test.p-value: 0.2796Paired t-test
Comparison: Change from baseline to Month 6: analysis was performed using paired t-test.p-value: 0.0066Paired t-test
Comparison: Change from baseline to Month 6: analysis was performed using paired t-test.p-value: 0.0081Paired t-test
Comparison: Change from baseline to Month 6: analysis was performed using paired t-test.p-value: 0.7853Paired t-test
Comparison: Change from baseline to Month 7: analysis was performed using paired t-test.p-value: 0.0039Paired t-test
Comparison: Change from baseline to Month 7: analysis was performed using paired t-test.p-value: 0.3057Paired t-test
Comparison: Change from baseline to Month 7: analysis was performed using paired t-test.p-value: 0.3374Paired t-test
Comparison: Change from baseline to Month 7: analysis was performed using paired t-test.p-value: 0.141Paired t-test
Comparison: Change from baseline to Month 8: analysis was performed using paired t-test.p-value: 0.0017Paired t-test
Comparison: Change from baseline to Month 8: analysis was performed using paired t-test.p-value: 0.0677Paired t-test
Comparison: Change from baseline to Month 8: analysis was performed using paired t-test.p-value: 0.1608Paired t-test
Comparison: Change from baseline to Month 8: analysis was performed using paired t-test.p-value: 0.0196Paired t-test
Secondary
Mean Monthly Hb Values
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).
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8
Population: ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mircera - CMUH | Mean Monthly Hb Values | Month 8 (n=26,19,19,64) | 11.5 g/dL | Standard Deviation 1 |
| Mircera - CMUH | Mean Monthly Hb Values | Month 4 (n=31,22,19,72) | 10.9 g/dL | Standard Deviation 1.3 |
| Mircera - CMUH | Mean Monthly Hb Values | Month 6 (n=28,20,19,67) | 10.9 g/dL | Standard Deviation 1 |
| Mircera - CMUH | Mean Monthly Hb Values | Month 5 (n=28,21,19,68) | 11.0 g/dL | Standard Deviation 1.1 |
| Mircera - CMUH | Mean Monthly Hb Values | Month 7 (n=27,20,19,66) | 11.3 g/dL | Standard Deviation 0.9 |
| Mircera - CMUH | Mean Monthly Hb Values | Baseline (n=35,26,22,83) | 10.7 g/dL | Standard Deviation 0.6 |
| Mircera - CMUH | Mean Monthly Hb Values | Month 1 (n=35,26,22,83) | 10.7 g/dL | Standard Deviation 1.2 |
| Mircera - CMUH | Mean Monthly Hb Values | Month 2 (n=34,26,21,81) | 10.8 g/dL | Standard Deviation 1.4 |
| Mircera - CMUH | Mean Monthly Hb Values | Month 3 (n=33,22,20,75) | 10.8 g/dL | Standard Deviation 1.2 |
| Mircera - KMUH | Mean Monthly Hb Values | Month 7 (n=27,20,19,66) | 10.9 g/dL | Standard Deviation 1.5 |
| Mircera - KMUH | Mean Monthly Hb Values | Month 5 (n=28,21,19,68) | 10.5 g/dL | Standard Deviation 1.2 |
| Mircera - KMUH | Mean Monthly Hb Values | Baseline (n=35,26,22,83) | 11.1 g/dL | Standard Deviation 0.6 |
| Mircera - KMUH | Mean Monthly Hb Values | Month 4 (n=31,22,19,72) | 10.5 g/dL | Standard Deviation 1.3 |
| Mircera - KMUH | Mean Monthly Hb Values | Month 3 (n=33,22,20,75) | 10.9 g/dL | Standard Deviation 1 |
| Mircera - KMUH | Mean Monthly Hb Values | Month 1 (n=35,26,22,83) | 11.3 g/dL | Standard Deviation 0.8 |
| Mircera - KMUH | Mean Monthly Hb Values | Month 6 (n=28,20,19,67) | 10.4 g/dL | Standard Deviation 1.2 |
| Mircera - KMUH | Mean Monthly Hb Values | Month 2 (n=34,26,21,81) | 10.9 g/dL | Standard Deviation 1.1 |
| Mircera - KMUH | Mean Monthly Hb Values | Month 8 (n=26,19,19,64) | 10.8 g/dL | Standard Deviation 0.9 |
| Mircera - BTCH | Mean Monthly Hb Values | Baseline (n=35,26,22,83) | 10.8 g/dL | Standard Deviation 0.4 |
| Mircera - BTCH | Mean Monthly Hb Values | Month 2 (n=34,26,21,81) | 11.2 g/dL | Standard Deviation 1.2 |
| Mircera - BTCH | Mean Monthly Hb Values | Month 6 (n=28,20,19,67) | 11.4 g/dL | Standard Deviation 0.9 |
| Mircera - BTCH | Mean Monthly Hb Values | Month 1 (n=35,26,22,83) | 10.9 g/dL | Standard Deviation 1 |
| Mircera - BTCH | Mean Monthly Hb Values | Month 3 (n=33,22,20,75) | 11.8 g/dL | Standard Deviation 1 |
| Mircera - BTCH | Mean Monthly Hb Values | Month 4 (n=31,22,19,72) | 11.4 g/dL | Standard Deviation 0.9 |
| Mircera - BTCH | Mean Monthly Hb Values | Month 5 (n=28,21,19,68) | 11.5 g/dL | Standard Deviation 0.9 |
| Mircera - BTCH | Mean Monthly Hb Values | Month 7 (n=27,20,19,66) | 11.0 g/dL | Standard Deviation 0.9 |
| Mircera - BTCH | Mean Monthly Hb Values | Month 8 (n=26,19,19,64) | 11.1 g/dL | Standard Deviation 1 |
| Mircera | Mean Monthly Hb Values | Month 5 (n=28,21,19,68) | 11.0 g/dL | Standard Deviation 1.1 |
| Mircera | Mean Monthly Hb Values | Month 6 (n=28,20,19,67) | 10.9 g/dL | Standard Deviation 1.1 |
| Mircera | Mean Monthly Hb Values | Month 1 (n=35,26,22,83) | 10.9 g/dL | Standard Deviation 1 |
| Mircera | Mean Monthly Hb Values | Month 8 (n=26,19,19,64) | 11.2 g/dL | Standard Deviation 1 |
| Mircera | Mean Monthly Hb Values | Month 7 (n=27,20,19,66) | 11.1 g/dL | Standard Deviation 1.1 |
| Mircera | Mean Monthly Hb Values | Month 2 (n=34,26,21,81) | 10.9 g/dL | Standard Deviation 1.3 |
| Mircera | Mean Monthly Hb Values | Month 4 (n=31,22,19,72) | 10.9 g/dL | Standard Deviation 1.3 |
| Mircera | Mean Monthly Hb Values | Month 3 (n=33,22,20,75) | 11.1 g/dL | Standard Deviation 1.1 |
| Mircera | Mean Monthly Hb Values | Baseline (n=35,26,22,83) | 10.8 g/dL | Standard Deviation 0.6 |
Secondary
Mean Time Participants Spent Having Hb Concentration Within Target Range
Target Hb concentration was between 10.0 and 12.0 g/dL.
Time frame: Weeks 1 to 32
Population: ITT Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mircera - CMUH | Mean Time Participants Spent Having Hb Concentration Within Target Range | 112.6 days | Standard Deviation 75.6 |
| Mircera - KMUH | Mean Time Participants Spent Having Hb Concentration Within Target Range | 105.0 days | Standard Deviation 74 |
| Mircera - BTCH | Mean Time Participants Spent Having Hb Concentration Within Target Range | 107.6 days | Standard Deviation 56.7 |
| Mircera | Mean Time Participants Spent Having Hb Concentration Within Target Range | 108.9 days | Standard Deviation 69.8 |
Secondary
Percentage of Participants Requiring Dose Adjustments
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.
Time frame: 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 8
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 6 to 7: Not Done (n=64) | 12.5 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Baseline to Month 1: Increase (n=81) | 7.4 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Baseline to Month 1: No Change (n=81) | 61.7 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Baseline to Month 1: Decrease (n=81) | 21.0 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Baseline to Month 1: Not Done (n=81) | 9.9 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Month 1 to Month 2: Increase (n=75) | 4.0 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Month 1 to Month 2: No Change (n=75) | 69.3 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Month 1 to Month 2: Decrease (n=75) | 16.0 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Month 1 to Month 2: Not Done (n=75) | 10.7 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 2 to 3: Increase (n=72) | 6.9 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 2 to 3: No Change (n=72) | 59.7 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 2 to 3: Decrease (n=72) | 19.4 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 2 to 3: Not Done (n=72) | 13.9 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 3 to 4: Increase (n=68) | 4.4 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 3 to 4: No Change (n=68) | 64.7 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 3 to 4: Decrease (n=68) | 16.2 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 3 to 4: Not Done (n=68) | 14.7 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 4 to 5: Increase (n=67) | 11.9 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 4 to 5: No Change (n=67) | 61.2 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 4 to 5: Decrease (n=67) | 11.9 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 4 to 5: Not Done (n=67) | 14.9 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 5 to 6: Increase (n=66) | 6.1 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 5 to 6: No Change (n=66) | 59.1 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 5 to 6: Decrease (n=66) | 21.2 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 5 to 6: Not Done (n=66) | 13.6 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 6 to 7: Increase (n=64) | 12.5 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 6 to 7: No Change (n=64) | 65.6 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 6 to 7: Decrease (n=64) | 9.4 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 7 to 8: Increase (n=64) | 3.1 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 7 to 8: No Change (n=64) | 84.4 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 7 to 8: Decrease (n=64) | 0.0 percentage of participants |
| Mircera - CMUH | Percentage of Participants Requiring Dose Adjustments | Months 7 to 8: Not Done (n=64) | 12.5 percentage of participants |