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This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A (0.4/150, 1x/ Week) | Experimental | Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) SC using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). |
|
| Cohort B (0.4/150, 1x/ 3 Weeks) | Experimental | Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). |
|
| Cohort C (0.4/150, 1x/ 4 Weeks) | Experimental | Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). |
|
| Cohort D (0.8/150, 1x/ Week) | Experimental |
| 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 |
|---|---|---|
| Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen | Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value. | From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21) |
| Measure | Description | Time Frame |
|---|---|---|
| Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen | Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA 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 or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value. |
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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 |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90073 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3. | |
| 17519064 | Derived | Locatelli F, Villa G, de Francisco AL, Albertazzi A, Adrogue HJ, Dougherty FC, Beyer U; BA16286 Study Investigators. Effect of a continuous erythropoietin receptor activator (C.E.R.A.) on stable haemoglobin in patients with CKD on dialysis: once monthly administration. Curr Med Res Opin. 2007 May;23(5):969-79. doi: 10.1185/030079907x182103. |
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A total of 137 participants were enrolled in this study conducted from 15 October 2001 to 7 July 2003 (core study period) and 19 September 2002 to 7 July 2005 (extension study period) at 22 centers (8 in Italy, 6 in the US, 4 in Germany, and 4 in Spain).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A (0.4/150, 1x/ Week) | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneous (SC) using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Period |
|
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Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
|
| Cohort E (0.8/150, 1x/ 3 Weeks) | Experimental | Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). |
|
| Cohort F (0.8/150, 1x/ 4 Weeks) | Experimental | Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). |
|
| Cohort G (1.2/150, 1x/ Week) | Experimental | Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). |
|
| Cohort H (1.2/150, 1x/ 3 Weeks) | Experimental | Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). |
|
| Cohort I (1.2/150, 1x/ 4 Weeks) | Experimental | Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each). |
|
| From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21) |
| Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | Mean 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) value is the measurements taken at screening assessment and run-in period (Weeks -2 and -1). | From Baseline (Day -28 to Day 1) to Week 126 |
| Mean Change in Pulse Rate | Mean change in pulse rate was reported. | Up to Week 126 |
| Number of Participants With Marked Laboratory Abnormalities | Participants with marked laboratory abnormalities were reported. Marked abnormality criteria: Serum glutamic oxaloacetic transaminase (SGOT); high >25 units per litre (U/L), albumin (low < 31 grams per litre [g/L]), total protein (< 60 g/L), phosphate (high >1.45 millimoles per litre [mmol/L]); Low <0.84 mmol/L), potassium (high >5 mmol/L; Low <3.5 mmol/L), platelets (low:<150×10^9/L), White blood cells ([WBCs]); high: 10.8×10^9/L and Low:4.3×10^9/L), basophils (high:>0.15×10^9/L), eosinophils (high:>0.70×10^9/L), lymphocytes (low:<1.50×10^9/L), and neutrophils (low:<1.83×10^9/L). | Up to Week 126 |
| Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths | 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 126 |
| San Jose |
| California |
| 95116-1906 |
| United States |
| Boston | Massachusetts | 02130 | United States |
| Cleveland | Ohio | 44106 | United States |
| Houston | Texas | 77030 | United States |
| Morgantown | West Virginia | 26506 | United States |
| Berlin | 10625 | Germany |
| Mannheim | 68167 | Germany |
| Villingen-Schwenningen | 78054 | Germany |
| Wiesloch | 69168 | Germany |
| Bari | 70124 | Italy |
| Bergamo | 24128 | Italy |
| Lecco | 23900 | Italy |
| Lodi | 26900 | Italy |
| Milan | 20122 | Italy |
| Modena | 41100 | Italy |
| Pavia | 27100 | Italy |
| Vicenza | 36100 | Italy |
| Barcelona | 08036 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28046 | Spain |
| Málaga | 29010 | Spain |
| Santander | 39008 | Spain |
| FG001 | Cohort B (0.4/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| FG002 | Cohort C (0.4/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| FG003 | Cohort D (0.8/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| FG004 | Cohort E (0.8/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| FG005 | Cohort F (0.8/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| FG006 | Cohort G (1.2/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| FG007 | Cohort H (1.2/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| FG008 | Cohort I (1.2/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| FG009 | RO0503821 (1x/ Week) | Eligible participants were administered SC RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kilogram of the previous weekly ESA dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| FG010 | RO0503821 (1x/ 3 Weeks) | Eligible participants were administered SC RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| FG011 | RO0503821 (1x/ 4 Weeks) | Eligible participants were administered SC RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| COMPLETED |
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| NOT COMPLETED |
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| Extension Year 1 |
|
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| Extension Year 2 |
|
|
The Intent-to-Treat (ITT) population was considered for analysis which included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A (0.4/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| BG001 | Cohort B (0.4/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| BG002 | Cohort C (0.4/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| BG003 | Cohort D (0.8/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| BG004 | Cohort E (0.8/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| BG005 | Cohort F (0.8/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| BG006 | Cohort G (1.2/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| BG007 | Cohort H (1.2/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| BG008 | Cohort I (1.2/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| 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 |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| 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 | Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen | Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value. | The ITT population was considered for analysis which included all randomized participants. | Posted | Median | Inter-Quartile Range | gram per deciliter | From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21) |
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| Secondary | Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen | Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA 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 or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value. | The ITT population was considered for analysis which included all randomized participants. | Posted | Median | Inter-Quartile Range | Percentage of Hct | From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21) |
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| Secondary | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis | Mean 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) value is the measurements taken at screening assessment and run-in period (Weeks -2 and -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 | Millimeters of Mercury | From Baseline (Day -28 to Day 1) to Week 126 |
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| Secondary | Mean Change in Pulse Rate | Mean change in pulse rate was reported. | The safety population was considered for analysis which included all participants who received at least one dose of study drug. Participants with available data at the time of evaluation were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Up to Week 126 |
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| Secondary | Number of Participants With Marked Laboratory Abnormalities | Participants with marked laboratory abnormalities were reported. Marked abnormality criteria: Serum glutamic oxaloacetic transaminase (SGOT); high >25 units per litre (U/L), albumin (low < 31 grams per litre [g/L]), total protein (< 60 g/L), phosphate (high >1.45 millimoles per litre [mmol/L]); Low <0.84 mmol/L), potassium (high >5 mmol/L; Low <3.5 mmol/L), platelets (low:<150×10^9/L), White blood cells ([WBCs]); high: 10.8×10^9/L and Low:4.3×10^9/L), basophils (high:>0.15×10^9/L), eosinophils (high:>0.70×10^9/L), lymphocytes (low:<1.50×10^9/L), and neutrophils (low:<1.83×10^9/L). | 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 126 |
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| Secondary | Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths | 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 126 |
|
Up to Week 126
SAEs and non-serious AEs are reported in safety analysis set, which consists of all participants who received at least one dose of study drug. 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 were administered subcutaneous (SC) RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). | 15 | 48 | 36 | 48 | ||
| EG001 | RO0503821 (1x/ 3 Weeks) | Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). | 13 | 46 | 30 | 46 | ||
| EG002 | RO0503821 (1x/ 4 Weeks) | Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). | 20 | 43 | 39 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Central line infection | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Catheter sepsis | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Peritoneal tuberculosis | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Arteriopathic disease | Vascular disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Necrosis ischaemic | Vascular disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Peripheral occlusive disease | Vascular disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Vascular disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Venous stenosis | Vascular disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (5.1) | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (5.1) | Systematic Assessment |
| |
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA (5.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (5.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (5.1) | Systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA (5.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Hyperparathyroidism Secondary | Endocrine disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Metastatic Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | Systematic Assessment |
| |
| Cataract Operation | Surgical and medical procedures | MedDRA (5.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Central line infection | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (5.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (5.1) | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (5.1) | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (5.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Carotid artery atheroma | Nervous system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (5.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (5.1) | 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/ 3 weeks (0.4, 0.8 and 1.2 dose group) | Estimated Conversion Factor 90% CI | 0.72 | 2-Sided | 90 | 0.55 | 0.86 | To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero. | No | Superiority or Other |
| All cohorts with dosing frequency 1x/ 4 weeks (0.4, 0.8 and 1.2 dose group) | Estimated Conversion Factor 90% CI | 0.93 | 2-Sided | 90 | 0.81 | 1.09 | To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero. | No | Superiority or Other |
| OG002 | Cohort C (0.4/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG003 | Cohort D (0.8/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG004 | Cohort E (0.8/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG005 | Cohort F (0.8/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG006 | Cohort G (1.2/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG007 | Cohort H (1.2/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG008 | Cohort I (1.2/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
|
|
| OG002 | Cohort C (0.4/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG003 | Cohort D (0.8/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG004 | Cohort E (0.8/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG005 | Cohort F (0.8/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG006 | Cohort G (1.2/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG007 | Cohort H (1.2/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG008 | Cohort I (1.2/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
|
|
| OG003 | Cohort D (0.8/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG004 | Cohort E (0.8/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG005 | Cohort F (0.8/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG006 | Cohort G (1.2/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG007 | Cohort H (1.2/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG008 | Cohort I (1.2/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
|
|
| OG002 | Cohort C (0.4/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG003 | Cohort D (0.8/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG004 | Cohort E (0.8/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG005 | Cohort F (0.8/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG006 | Cohort G (1.2/150, 1x/ Week) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG007 | Cohort H (1.2/150, 1x/ 3 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG008 | Cohort I (1.2/150, 1x/ 4 Weeks) | Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
|
|
| OG001 | RO0503821 (1x/ 3 Weeks) | Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| OG002 | RO0503821 (1x/ 4 Weeks) | Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
|
|