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This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. 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 [0.25/150 1x/week]) | Experimental | Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% 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 2 (RO0503821 [0.25/150 1x/2week]) | Experimental | Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two 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 3 (RO0503821 [0.4/150 1x/week]) | Experimental | Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% 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 4 (RO0503821 [0.4/150 1x/2week]) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | Differing doses and frequencies of iv 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 Week -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 value. | From Baseline (Day -28 to Day 1) to EOIT (Week 19) |
| 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 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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35211 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37651553 | Derived | Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2. | |
| 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. |
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A total of 91 participants were enrolled in this study conducted from 19 March 2002 to 08 June 2005 at 14 Sites in United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (RO0503821 [0.25/150 1x/ Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% 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 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two 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 5 (RO0503821 [0.6/150 1x/week]) | Experimental | Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% 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 6 (RO0503821 [0.6/150 1x/2week]) | Experimental | Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two 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). |
|
| From Baseline (Day -28 to Day 1) to EOIT (Week 19) |
| 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 |
| Number of Participants With Marked Laboratory Abnormalities | Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10^9/L), Platelets (100 - 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 - 220 U/L), Aspartate aminotransferase (ASAT) (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), Glucose (2.80 - 11.10 mmol/L). | Up to Week 126 |
| 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) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). | From Baseline (Day -28 to Day 1) to Week 126 |
| Mean Change in Pulse Rate | Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported. | Up to Week 126 |
| Los Angeles |
| California |
| 90095 |
| United States |
| Maywood | Illinois | 60153 | United States |
| Louisville | Kentucky | 40202-1718 | United States |
| Detroit | Michigan | 48202-2689 | United States |
| Detroit | Michigan | 48236 | United States |
| Brooklyn Center | Minnesota | 55430 | United States |
| Las Vegas | Nevada | 89106 | United States |
| Paterson | New Jersey | 07503 | United States |
| Brooklyn | New York | 11203 | United States |
| Mineola | New York | 11501 | United States |
| New York | New York | 10128 | United States |
| Nashville | Tennessee | 37232 | United States |
| Morgantown | West Virginia | 26506 | United States |
| FG001 | Cohort 2 (RO0503821 [0.25/150 1x/2 Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two 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 3 (RO0503821 [0.4/150 1x/ Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% 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). |
| FG003 | Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two 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). |
| FG004 | Cohort 5 (RO0503821 [0.6/150 1x/ Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% 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). |
| FG005 | Cohort 6 (RO0503821 [0.6/150 1x/2 Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two 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). |
| FG006 | RO0503821 (1x/Week) | Eligible participants were administered intravenously (IV) RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) once weekly (1x/ week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| FG007 | RO0503821 (1x/2Week) | Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Year 1 |
|
|
| Extension Year 2 |
|
|
The Intent-to-Treat (ITT) population was used for the analysis. It was defined as all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (RO0503821 [0.25/150 1x/Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% 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 2 (RO0503821 [0.25/150 1x/2 Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two 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 3 (RO0503821 [0.4/150 1x/Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% 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). |
| BG003 | Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two 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). |
| BG004 | Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% 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). |
| BG005 | Cohort 6 (RO0503821 [0.6/150 1x/2 Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two 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). |
| BG006 | 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 Week -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 value. | The Intent-to-Treat (ITT) population was defined as all randomized participants. | Posted | Median | Inter-Quartile Range | g/dL | From Baseline (Day -28 to Day 1) to EOIT (Week 19) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 value. | The Intent-to-Treat (ITT) population was defined as all randomized participants. | Posted | Median | Inter-Quartile Range | g/dL | From Baseline (Day -28 to Day 1) to EOIT (Week 19) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Marked Laboratory Abnormalities | Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10^9/L), Platelets (100 - 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 - 220 U/L), Aspartate aminotransferase (ASAT) (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), Glucose (2.80 - 11.10 mmol/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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) values were calculated as the mean of the screening assessment (SA) 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 | mm HG | From Baseline (Day -28 to Day 1) to Week 126 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Pulse Rate | Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported. | 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 126 |
|
Up to Week 126
Serious adverse events and non-serious adverse events are reported in Safety Analysis population. 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 (1/Week) | Eligible participants were administered IV RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). | 20 | 46 | 34 | 46 | ||
| EG001 | RO0503821 (1/2week) | Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). | 20 | 45 | 30 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Catheter sepsis | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Upper gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 5.1 | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 5.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 5.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 5.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 5.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 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 |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Vascular disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Ischaemic ulcer | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 5.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Ileostomy closure | Surgical and medical procedures | MedDRA 5.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 5.1 | Systematic Assessment |
| |
| Procedural hypotension | 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 |
| |
| Fatigue | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Cataract | Eye 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 61 6878333 | 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 1 X /2 Week |
| Estimated Conversion Factor 90% CI |
| 0.61 |
| 2-Sided |
| 90 |
| 0.53 |
| 0.76 |
To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb change. |
| No |
| Superiority or Other |
| OG002 | Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% 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). |
| OG003 | Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two 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). |
| OG004 | Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% 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). |
| OG005 | Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two 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). |
|
|
| OG001 | RO0503821 (1x/2Week) | Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each). |
|
|
| OG002 | Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% 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). |
| OG003 | Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two 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). |
| OG004 | Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% 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). |
| OG005 | Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two 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). |
|
|
| OG002 | Cohort 3 (RO0503821 [0.4/150 1x/Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% 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). |
| OG003 | Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two 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). |
| OG004 | Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% 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). |
| OG005 | Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two 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). |
|
|
| Cohort 3 (RO0503821 [0.4/150 1x/Week]) |
Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% 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). |
| OG003 | Cohort 4 (RO0503821 [0.4/150 1x/2week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two 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). |
| OG004 | Cohort 5 (RO0503821 [0.6/150 1x/Week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% 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). |
| OG005 | Cohort 6 (RO0503821 [0.6/150 1x/2week]) | Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two 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). |
|
|