| Primary | Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period | Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported. | Per-protocol population included all randomized participants who received at least one dose of the study drug and met all study entry criteria with no major protocol violations. Participants with available data at the time of evaluation were analyzed. | Posted | | Mean | Standard Deviation | g/dL | | From Baseline (D 0) to 9 months | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.32± 1.31
- OG0010.51± 1.33
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| Secondary | Percentage of Participants With Safety-Related Hb Measures | Safety-related Hb measures included percentage of participants with Hb value > 13 g/dL, 13.5 g/dL, increase in Hb value from baseline by > 2 g/dL or decrease in Hb value from baseline by > 2 g/dL at any time during the study. | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. | Posted | | Number | | Percentage of participants | | Up to Month 9 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
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| Secondary | Number of Participants With Marked Laboratory Abnormalities | Participants with marked laboratory abnormalities in hematology and clinical chemistry parameters are reported. Hematology laboratory parameters included hematocrit fraction, hemoglobin, platelets, white blood cells (WBCs) and clinical chemistry parameters included aspartate aminotransferase ([AST], alanine aminotransferase ([ALT], creatine phosphokinase (CPK), alkaline phosphatase, albumin, potassium, fasting glucose and phosphate. | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'. | Posted | | Number | | Participants | | Up to Month 9 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 |
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| Secondary | Mean Change From Baseline in Iron | Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in iron to D1 of Months 2, 3, 4, 5, 6, 7, 8 is reported. | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'. | Posted | | Mean | Standard Deviation | micromole per litre | | From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
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| Secondary | Mean Change From Baseline in Ferritin | Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in ferritin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported. | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'. | Posted | | Mean | Standard Deviation | microgram per litre | | From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
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| Secondary | Mean Change From Baseline in Transferrin Saturation | Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported. | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'. | Posted | | Mean | Standard Deviation | Percentage of Transferrin Saturation | | From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
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| Secondary | Mean Change From Baseline in Serum Transferrin | Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in serum transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported. | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'. | Posted | | Mean | Standard Deviation | milligram (mg) per dL | | From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
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| Secondary | Mean Change From Baseline in Total Iron-binding Capacity | Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in total Iron-binding Capacity to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported. | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'. | Posted | | Mean | Standard Deviation | mg per dL | | From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
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| Secondary | Mean Change From Baseline in Temperature | | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'. | Posted | | Mean | Standard Deviation | Degree Celsius | | From Baseline (D 0) to D1 and D15 of M7, M8 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
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| Secondary | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'. | Posted | | Mean | Standard Deviation | millimeter of mercury | | From Baseline (D 0) to D1 and D15 of M7, M8 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
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| Secondary | Mean Change From Baseline in Pulse Rate | | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'. | Posted | | Mean | Standard Deviation | Beats per minute | | From Baseline (D 0) to D1 and D15 of M7, M8 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
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| Secondary | Mean Change From Baseline in Weight | | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'. | Posted | | Mean | Standard Deviation | kilogram | | From Baseline (D 0) to D1 and D15 of M7, M8 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
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| Secondary | Number of Participants With Anti-erythropoietin Antibody in Human Serum | Erythropoietin is human protein which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with erythropoietin, anti-erythropoietin antibody (Anti-EPO) may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond to treatment. Number of participants with anti-EPO antibody that are quantifiable and those that were "below the limit of quantification (BLQ)" at Baseline (Day 0) and Visit 17 (Month 9 [M 9]) or final visit/early termination in human serum samples are reported. | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. | Posted | | Number | | Participants | | Up to Month 9 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. |
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| Secondary | Number of Participants With Anti-RO0503821 Antibody in Human Serum | RO0503821 is a chemically modified erythropoietin which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with RO0503821, anti-RO0503821 antibody may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond. Number of participants with anti- RO0503821 antibody that are quantifiable and those that were "BLQ" at Baseline (Day 0) and Visit 17 (M 9) or final visit/early termination in human serum samples are reported. | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. | Posted | | Number | | Participants | | Up to Month 9 | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. |
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| Secondary | Number of Participants With Any AEs, Any Serious Adverse Events and Death | An AE is untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalisation, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly. | Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. | Posted | | Number | | Participants | | Up to 9 months | | | | ID | Title | Description |
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| OG000 | RO0503821 | Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so. | | OG001 | Epoetin Alfa | Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so. |
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