| Primary | Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period | The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter [g/dL]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36. | Per-protocol population included participants who received at least one dose of C.E.R.A. and had data of at least one follow-up variable excluding those participants who had not adhere the inclusion/exclusion criteria, had less than 3 recorded Hb values, and received any other epoetin alpha and blood transfusion in Weeks 0 to 44. | Posted | | Number | | percentage of participants | | EEP (Week 29 to Week 36) | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Difference of response rates | -0.02 | | | 2-Sided | 95 | -0.25 | 0.20 | | | | | Non-Inferiority or Equivalence (legacy) | Mean Hb within target range during efficacy evaluation period within plus or minus 1 g/dL of their reference Hb and between the target range with a non-inferiority limit of -0.15. | |
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| Secondary | Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period | The Baseline (Safety Verification Period) was from Week - 4 to Week -1. | The analysis was performed on ITT population. | Posted | | Mean | Standard Deviation | g/dL | | Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36) | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period | Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period. | The analysis was performed on ITT population. | Posted | | Number | | percentage of participants | | EEP (Weeks 29 to 36) | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period | Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented. | The analysis was performed on ITT population. | Posted | | Mean | Standard Deviation | days | | EEP (Week 29 to Week 36) | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | 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 and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28. | The analysis was performed on ITT population. | Posted | | Number | | participants | | DTP (Weeks 0 to 28) | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | 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 and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36. | The analysis was performed on ITT population. | Posted | | Number | | participants | | EEP (Weeks 29 to 36) | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Number of Participants Received 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. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP. | The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not | Posted | | Number | | participants | | Up to Week 28 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Mean Values of Hemoglobin Concentration at Baseline and Week 36 | The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented. | The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | g/dL | | Baseline and Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Mean Values of Hematocrit at Baseline and Week 36 | Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented. | The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | fraction | | Baseline and Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Mean Values of Mean Corpuscular Volume at Baseline and Week 36 | Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented. | The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | femtoliters | | Baseline and Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Mean Values of Leukocytes and Platelets Count at Baseline and Week 36 | The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented. | The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | 10^9/Litre | | Baseline and Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36 | Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36. | The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | micromoles per liter | | Baseline and Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36 | The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented. | The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | gram/litre | | Baseline and Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Mean Values of Ferritin Concentration at Baseline and Week 36 | Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented. | The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | micrograms per liter | | Baseline and Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Mean Values of Transferrin Saturation at Baseline and Week 36 | The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented. | The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point. | Posted | | Mean | Standard Deviation | percentage | | Baseline and Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36 | The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented. | The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point.. | Posted | | Mean | Standard Deviation | International units/Liter | | Baseline and Week 36 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Number of Participants With Adverse Events and Serious Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported. | The analysis was performed on Safety Population. | Posted | | Number | | participants | | Up to Week 40 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Number of Participants With Abnormal Changes in ECG From Baseline to Week 40 | Twelve-lead ECG was performed. | The analysis was performed on Safety population. | Posted | | Number | | participants | | From Baseline to Week 40 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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| Secondary | Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40 | Vital signs included blood pressure, pulse rate and body weight. | The analysis was performed on safety population. | Posted | | Number | | participants | | From Baseline to Week 40 | | | | ID | Title | Description |
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| OG000 | C.E.R.A. | Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks. | | OG001 | Epoetin Alpha | Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks. |
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