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This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week) | Experimental | Eligible participants will be receiving RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) at a dose of 0.15 microgram per kilogram (mcg/kg) subcutaneously (SC) once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
|
| Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
|
| Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
|
| Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | Differing doses and frequencies of sc administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes | The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19. | From Baseline (Day -28 to Day 1) to EOIT (Week 19) |
| Measure | Description | Time Frame |
|---|---|---|
| Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen | Hematocrit (Hct) levels at end of initial treatment under constant dosing regimen were reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35211 | United States | |||
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The study was conducted across 15 centers in 5 countries from 07 March 2002 until 23 November 2004 (last date of extension Year 2)
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week) | Eligible participants received RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) at a dose of 0.15 microgram per kilogram (mcg/kg) subcutaneously (SC) once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Treatment |
|
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Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
|
| Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
|
| Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
|
| Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
|
| Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
|
| Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
|
| From Baseline (Day -28 to Day 1) to EOIT (Week 19) |
| Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen | Reticulocyte levels at EOIT under constant dosing regimen was analysed and reported. Baseline (Day -28 to Day 1) reticulocyte values were calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed reticulocyte count before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19. | From Baseline (Day -28 to Day 1) to EOIT (Week 19) |
| Number of Participants With Any Serious Adverse Events and Any Adverse Events | An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only. | Up to Week 125 |
| Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time | Marked abnormality was defined as above and/or below a value (according to the Roche specified limits) which was considered to be potentially clinically relevant. The Roche reference range are: white blood cells (WBC) (3.0-18.0 10^9 cells/L), platelets (100-550 10^9 cells/L), alanine aminotransferase (ALT) [0-110 units per litre (U/L)], alkaline phosphatase (ALP) (0-220 U/L), aspartate aminotransferase (AST) (0-80 U/L), albumin >= 30 g/L, phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], potassium (2.9 - 5.8 mmol/L), total bilirubin (0-17 µmol/L), lymphocytes (1- 4.80 10^9 cells/L), eosinophils (0 - 0.45 10^9 cells/L), monocytes (0 - 0.8 10^9 cells/L), and neutrophils (1.80 - 7.70 10^9 cells/L). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time, all results for the two long term safety periods were displayed by dose schedule group only. | Up to Week 125 |
| Heart Rate Over Time | Heart rate was defined as the measure of heart beats per minute (bpm). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only. | Up to Week 125 |
| Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the SA (Week -3) and Run-in period (Week -2 and Week -1). | From Baseline (Day -28 to Day 1) to Week 125 |
| San Diego |
| California |
| 92103-8342 |
| United States |
| Detroit | Michigan | 48202-2689 | United States |
| Detroit | Michigan | 48236 | United States |
| Las Vegas | Nevada | 89106 | United States |
| Portland | Oregon | 97201-2940 | United States |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Mexico City | 14000 | Mexico |
| Monterrey | 64710 | Mexico |
| Gdansk | 80-211 | Poland |
| Krakow | 31-501 | Poland |
| Wroclaw | 50-417 | Poland |
| Belfast | BT9 7LJ | United Kingdom |
| London | SE22 8PT | United Kingdom |
| FG001 | Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week) | Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| FG002 | Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week) | Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| FG003 | Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week) | Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| FG004 | Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week) | Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| FG005 | Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week) | Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| FG006 | Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week) | Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| FG007 | Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week) | Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| FG008 | Cohort 9 (RO0503821, 1.8 mcg/kg 1x/3 Week) | Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| FG009 | RO0503821 (1x/Week) | Eligible participants received RO0503821 at the dose of either 0.15 mcg/kg (Cohort 1) or 0.3 mcg/kg (Cohort 2) or 0.6 mcg/kg (Cohort 3) SC once weekly over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| FG010 | RO0503821 (1x/2Week) | Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| FG011 | RO0503821 (1x/3week) | Eligible participants received RO0503821 at the dose of either 0.45 mcg/kg (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| COMPLETED |
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| NOT COMPLETED |
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| Extension Year 1 |
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| Extension Year 2 |
|
|
The safety population was considered for analysis which included all participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week) | Eligible participants received RO0503821 at a dose of 0.15 mcg/kg SC once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| BG001 | Cohort 2 (RO0503821,0.3 mcg/kg 1x/Week) | Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| BG002 | Cohort 3 (RO0503821,0.6 mcg/kg 1x/Week) | Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| BG003 | Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week) | Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period |
| BG004 | Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week) | Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| BG005 | Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week) | Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| BG006 | Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week) | Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| BG007 | Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week) | Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| BG008 | Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week) | Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes | The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19. | The Intent-to-Treat (ITT) population was defined as all randomized participants. Maximum number of participants with available data was reported. | Posted | Median | Inter-Quartile Range | gram/deciliter (g/dL) | From Baseline (Day -28 to Day 1) to EOIT (Week 19) |
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| Secondary | Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen | Hematocrit (Hct) levels at end of initial treatment under constant dosing regimen were reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19. | The ITT population was defined as all randomized participants. Maximum number of participants with available data was reported. | Posted | Median | Inter-Quartile Range | g/dL | From Baseline (Day -28 to Day 1) to EOIT (Week 19) |
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| Secondary | Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen | Reticulocyte levels at EOIT under constant dosing regimen was analysed and reported. Baseline (Day -28 to Day 1) reticulocyte values were calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed reticulocyte count before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19. | The ITT population was defined as all randomized participants. Maximum number of participants with available data was reported. | Posted | Median | Inter-Quartile Range | Cells x10^3/UL | From Baseline (Day -28 to Day 1) to EOIT (Week 19) |
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| Secondary | Number of Participants With Any Serious Adverse Events and Any Adverse Events | An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only. | The safety population was considered for analysis which included all participants who received at least one dose of study drug. | Posted | Number | participants | Up to Week 125 |
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| Secondary | Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time | Marked abnormality was defined as above and/or below a value (according to the Roche specified limits) which was considered to be potentially clinically relevant. The Roche reference range are: white blood cells (WBC) (3.0-18.0 10^9 cells/L), platelets (100-550 10^9 cells/L), alanine aminotransferase (ALT) [0-110 units per litre (U/L)], alkaline phosphatase (ALP) (0-220 U/L), aspartate aminotransferase (AST) (0-80 U/L), albumin >= 30 g/L, phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], potassium (2.9 - 5.8 mmol/L), total bilirubin (0-17 µmol/L), lymphocytes (1- 4.80 10^9 cells/L), eosinophils (0 - 0.45 10^9 cells/L), monocytes (0 - 0.8 10^9 cells/L), and neutrophils (1.80 - 7.70 10^9 cells/L). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time, all results for the two long term safety periods were displayed by dose schedule group only. | The safety population was considered for analysis which included all participants who received at least one dose of study drug. | Posted | Number | participants | Up to Week 125 |
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| Secondary | Heart Rate Over Time | Heart rate was defined as the measure of heart beats per minute (bpm). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only. | The safety population was considered for analysis which included all participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | bpm | Up to Week 125 |
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| Secondary | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the SA (Week -3) and Run-in period (Week -2 and Week -1). | The safety population was considered for analysis which included all participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | mmHg | From Baseline (Day -28 to Day 1) to Week 125 |
|
Up to Week125
SAEs and non SAEs are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RO0503821 (1x/Week) | Eligible participants received RO0503821 at the dose of either 0.15 mcg/kg (Cohort 1) or 0.3 mcg/kg (Cohort 2) or 0.6 mcg/kg (Cohort 3) SC once weekly over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. | 11 | 22 | 16 | 22 | ||
| EG001 | RO0503821 (1x/2Week) | Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. | 9 | 21 | 18 | 21 | ||
| EG002 | RO0503821 (1x/3week) | Eligible participants received RO0503821 at the dose of either 0.45 mcg/kg (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. | 12 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal failure acute | Renal and urinary disorders | 8.0 | Systematic Assessment |
| |
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Acute myocardial Infarction | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Prostatic disorder | Reproductive system and breast disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Renal Cyst Ruptured | Renal and urinary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Bronchitis Acute | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Clostridium Colitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Impaired Gastric Emptying | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Loss Of Consciousness | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Reversible Posterior Leukoencephalopathy Syndrome | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Vascular Pseudoaneurysm | Vascular disorders | 8.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | 8.0 | Systematic Assessment |
| |
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | 8.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | 8.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 8.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Bronchitis Acute | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | 8.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 8.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hyperparathyroidism Secondary | Endocrine disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | 8.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 8.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Pruritus Generalised | Skin and subcutaneous tissue disorders | 8.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 8.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
| |
| Arteriovenous Fistula Operation | Surgical and medical procedures | MedDRA (8.0) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
Not provided
Not provided
Not provided
| Male |
|
| All cohorts with dosing frequency 1X/ 2Week | Least square mean | 0.851 | Standard Error of the Mean | 0.228 | 2-Sided | 95 | 0.395 | 1.307 | To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified. | Superiority or Other |
| All cohorts with dosing frequency 1X /3 Week | Least square mean | 0.932 | Standard Error of the Mean | 0.222 | 2-Sided | 95 | 0.488 | 1.377 | To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified. | Superiority or Other |
| OG002 | Cohort 3 (RO0503821,0.6 mcg/kg 1x/Week) | Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG003 | Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week) | Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period |
| OG004 | Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week) | Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG005 | Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week) | Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG006 | Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week) | Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG007 | Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week) | Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG008 | Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week) | Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
|
|
| OG002 | Cohort 3 (RO0503821,0.6 mcg/kg 1x/Week) | Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG003 | Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week) | Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG004 | Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week) | Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG005 | Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week) | Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG006 | Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week) | Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG007 | Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week) | Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG008 | Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week) | Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
|
|
| OG001 | RO0503821 (1x/2Week) | Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG002 | RO0503821 (1x/3week) | Eligible participants received RO0503821 at the dose of either 0.45 mcg/kg (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
|
|
| OG001 | RO0503821 (1x/2week) | Eligible participants received RO0503821 at the dose of either 0.3 mcg/kg (Cohort 4) or 0.6 mcg/kg (Cohort 5) or 1.2 mcg/kg (Cohort 6) SC once every two weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG002 | RO0503821 (1x/3week) | Eligible participants received RO0503821 at the dose of either 0.45 mcg/kg (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
|
|
| OG002 | RO0503821 (1x/3week) | Eligible participants received RO0503821 at the dose of either 0.45 (Cohort 7) or 0.9 mcg/kg (Cohort 8) or 1.8 mcg/kg (Cohort 9) SC once every three weeks over a period of 18 weeks. Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
|
|
| OG002 | Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week) | Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG003 | Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week) | Eligible participants received RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG004 | Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week) | Eligible participants received RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG005 | Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week) | Eligible participants received RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG006 | Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week) | Eligible participants received RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG007 | Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week) | Eligible participants received RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
| OG008 | Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week) | Eligible participants received RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants were followed-up for one week post the treatment period. During extension Years 1 and 2, the participants remained at the same frequency of administration as that of core treatment period. |
|
|