| Primary | Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12) | Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL. | Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Weeks 8 to 12 (Last 4 weeks of treatment period) | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00057.89(48.29 to 67.08)
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| Secondary | Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12) | The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL. | Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study. | Posted | | Mean | Standard Deviation | gm/dL | | SVP (Weeks -2 to -1) and TP (Weeks 8 to 12) | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL | Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL. | Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study. | Posted | | Mean | Standard Deviation | Weeks | | Up to Week 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths | Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Safety population included all enrolled participants who received at least one dose of study drug. | Posted | | Number | | Number of participants | | Up to Week 14 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Change From Baseline in Heart Rate Over Time | Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | Beats per minute (bpm) | | From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time | Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter. | Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | mmHg | | From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Number of Participants With Abnormal Electrocardiogram | Participants with abnormal electrocardiogram were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point. | Posted | | Number | | Number of participants | | At Week -2 and Week 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Values of White Blood Cells and Platelets Over Time | Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | Per cubic millimeter | | At Weeks -2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Values of Hypochromic Red Blood Cells Over Time | Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | Percentage of RBCs | | At Weeks -2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Corpuscular Volume Levels Over Time | Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | femtoliters | | At Weeks -2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time | Mean values of serum iron and total iron binding capacity (TIBC) were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | microgram per deciliter | | At Weeks -2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Values of Serum Ferritin Over Time | Mean values of serum ferritin were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | nanogram per mililiter | | At Weeks -2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Values of Transferrin Over Time | Mean values of transferrin were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | miligram per mililiter | | At Weeks -2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Values of Transferrin Saturation Over Time | Mean values of Transferrin Saturation (TSAT) were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | Percentage | | At Weeks -2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Values of Serum Albumin and Serum Globulin Over Time | Mean values of serum albumin and serum globulin were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | gram per deciliter | | At Weeks -2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time | Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | units per litre | | At Weeks -2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time | Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | miligram per deciliter | | At Weeks -2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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| Secondary | Mean Values of Serum Sodium and Serum Potassium Over Time | Mean values of serum sodium and serum potassium were reported. | Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | millimole per liter | | At Weeks -2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Mircera | Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. |
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