| Primary | Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period | The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36. | The primary analysis was performed on per protocol (PP) population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36. | Posted | | Mean | Standard Deviation | g/dL | | Baseline (Week 0) and from Week 29 to Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP | Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36. | The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From Week 29 to Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period | The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36. | The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36. | Posted | | Mean | Standard Deviation | days | | From Week 29 to Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | The Number of Participants Who Required Dose Adjustments During the Dose Titration Period | The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28. | The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36. | Posted | | Number | | participants | | From Week 0 to Week 28 (DTP) | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Time to Achievement of Response During the Efficacy Evaluation Period | The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36. | The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36. | Posted | | Mean | Standard Deviation | days | | From Week 29 to Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.. |
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| Secondary | Number of Participants With Red Blood Cells Transfusions. | The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. | The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. | Posted | | Number | | participants | | Up to Week 52 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Mean Values of Laboratory Parameter : Hb Concentration | The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | g/dL | | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Mean Values of Laboratory Parameter : Hematocrit | Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | fraction | | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration | The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | millimoles per litre | | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity | The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Mean Values of Laboratory Parameter : Serum Creatinine | The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented. | The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline (Week 0), and Week 32 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Mean Values of Laboratory Parameter: C Reactive Protein | The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | milligrams per liter | | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration | The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | grams per liter | | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Mean Values of Laboratory Parameter: Ferritin Concentration | The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | micrograms per liter | | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count | The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | 10^9 cells/liter | | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | Mean Values of Laboratory Parameters: Transferrin Saturation | The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented. | The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | percentage of saturation | | Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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| Secondary | The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period | The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36. | The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36. | Posted | | Number | | participants | | From Week 29 to Week 36 (EEP) | | | | ID | Title | Description |
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| OG000 | C.E.R.A | Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range. |
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