| Primary | Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period | The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16. | The intent-to-treat (ITT) population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented. | Posted | | Mean | Standard Deviation | gram/deciliter (g/dL) | | Baseline (Week 0) and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
| | | Title | Denominators | Categories |
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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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| | t-test, 2 sided | | <0.0001 | Paired t-test was used to estimation of p-value. | | | | | 2-Sided | | | | | | | No | Superiority or Other | | |
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| Secondary | Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter | Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks. | The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented. | Posted | | Mean | Standard Deviation | Weeks | | Up to Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 | The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented. | The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented. | Posted | | Mean | Standard Deviation | Weeks | | Week 12 to Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 | The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented. | The ITT population included all participants who received at least one dose of the study drug. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 to Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Number of Participants With Adverse Events, Serious Adverse Events and Deaths | An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. | Posted | | Number | | Participants | | Up to Week 18 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Number of Participants With Abnormal Electrocardiogram | Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Number | | Participants | | Up to Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Number of Participants With Reports of Blood Transfusions | Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons. | The ITT population included all participants who receive at least one dose of study drug. Participants available at the time of assessment were included. | Posted | | Number | | Participants | | Up to Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Number of Participants With Reports of Anti-Epoetin Antibodies | Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA. | The ITT population included all participants who receive at least one dose of study drug. | Posted | | Number | | Participants | | Up to Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean White Blood Cell Count Over Time | The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | cells per cubic millimeter | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Value of Mean Corpuscular Volume Over Time | Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | Femtoliter | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Hypochromic Red Blood Cells Over Time | Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | cells per cubic millimeter | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Platelet Count Over Time | Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | cells per cubic millimeter | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Serum Iron Over Time | Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | microgram/deciliter (mcg/dL) | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Serum Ferritin Over Time | Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | nanogram /milliliter (ng/mL) | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Transferrin Over Time | Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | milligram per deciliter (mg/dL) | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Total Iron-binding Capacity Over Time | Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | mcg/dL | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Transferrin Saturation Over Time | Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | Percentage of transferrin saturation | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Serum Albumin Over Time | Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | g/dL | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Serum Globulin Over Time | Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | g/dL | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Serum Creatinine Over Time | Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Blood Urea Nitrogen Over Time | Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Serum Potassium Over Time | Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | millimoles per liter (mmol/L) | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Serum Sodium Over Time | Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Serum Phosphate Over Time | Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Serum Bilirubin Over Time | Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Aspartate Transaminase Over Time | Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | Units/Liter (U/L) | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Alanine Aminotransferase Over Time | Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | U/L | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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| Secondary | Mean Serum Alkaline Phosphatase Over Time | Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point. | Posted | | Mean | Standard Deviation | U/L | | Baseline (Week 0), Week 4, Week 10, and Week 16 | | | | ID | Title | Description |
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| OG000 | MIRCERA | Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period. |
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