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This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is <200 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialysis | Procedure | regular haemodialysis or peritoneal dialysis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range | Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported. | Weeks 1 to 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Monthly Hb Values | The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0). | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 |
| Change in Hb Concentration Between Reference and Treatment Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung City | 807 | Taiwan | ||||
Efficacy results are reported separately for each of the 3 centers involved in the study [China Medical University Hospital (CMUH); Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH); and Buddhist Tzu Chi General Hospital (BTCH)] as well as for overall treatment arm, unless otherwise specified.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mircera | Participants received Mircera (epoetin beta-methoxy polyethylene glycol) 80, 120, 200, or 360 micrograms (mcg) (based on the weekly dose of erythropoiesis stimulating agent [ESA] participant received in the week preceding the switch to Mircera [Week -1]) by intravenous (IV) or subcutaneous (SC) injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on hemoglobin (Hb) level. This arm includes participants enrolled at all 3 centers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) population included 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mircera | Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level. This arm includes participants enrolled at all 3 centers. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range | Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported. | ITT Population. | Posted | Number | percentage of participants | Weeks 1 to 32 |
|
8 months
Safety population included all enrolled participants. Adverse events are reported for overall treatment arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mircera | Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level. This arm includes participants enrolled at all 3 centers. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperparathyroidism | Endocrine disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-La Roche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003956 | Dialysis |
| C508420 | continuous erythropoietin receptor activator |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055598 | Chemical Phenomena |
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| methoxy polyethylene glycol-epoetin beta [Mircera] |
| Drug |
once monthly, subcutaneously or intravenously, for 32 weeks |
|
The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0). |
| Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 |
| Mean Time Participants Spent Having Hb Concentration Within Target Range | Target Hb concentration was between 10.0 and 12.0 g/dL. | Weeks 1 to 32 |
| Percentage of Participants Requiring Dose Adjustments | Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm. | Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8 |
| New Taiepei City |
| Taiwan |
| Taichung | 404 | Taiwan |
| Refused Treatment |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Mircera - KMUH |
Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level. This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH). |
| OG002 | Mircera - BTCH | Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level. This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH). |
| OG003 | Mircera | Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level. This arm includes participants enrolled at all 3 centers. |
|
|
| Secondary | Mean Monthly Hb Values | The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0). | ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively. | Posted | Mean | Standard Deviation | g/dL | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 |
|
|
|
| Secondary | Change in Hb Concentration Between Reference and Treatment Period | The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0). | ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively. | Posted | Mean | Standard Deviation | g/dL | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8 |
|
|
|
|
| Secondary | Mean Time Participants Spent Having Hb Concentration Within Target Range | Target Hb concentration was between 10.0 and 12.0 g/dL. | ITT Population. | Posted | Mean | Standard Deviation | days | Weeks 1 to 32 |
|
|
|
| Secondary | Percentage of Participants Requiring Dose Adjustments | Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm. | ITT population. Here, number of participants analyzed signifies participants who were evaluable for this outcome and n signifies participants who were evaluable for specified time-point. | Posted | Number | percentage of participants | Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8 |
|
|
|
| 14 |
| 86 |
| 79 |
| 86 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Chronic hepatitis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Septic embolus | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA 15.0 | Non-systematic Assessment |
|
| Labile blood pressure | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Haemodialysis complication | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Month 1 (n=35,26,22,83) |
|
| Month 2 (n=34,26,21,81) |
|
| Month 3 (n=33,22,20,75) |
|
| Month 4 (n=31,22,19,72) |
|
| Month 5 (n=28,21,19,68) |
|
| Month 6 (n=28,20,19,67) |
|
| Month 7 (n=27,20,19,66) |
|
| Month 8 (n=26,19,19,64) |
|
| Change at Month 2 (n=34,26,21,81) |
|
| Change at Month 3 (n=33,22,20,75) |
|
| Change at Month 4 (n=31,22,19,72) |
|
| Change at Month 5 (n=28,21,19,68) |
|
| Change at Month 6 (n=28,20,19,67) |
|
| Change at Month 7 (n=27,20,19,66) |
|
| Change at Month 8 (n=26,19,19,64) |
|
| 0.5737 |
| 2-Sided |
| No |
| Superiority or Other |
| Change from baseline to Month 1: analysis was performed using paired t-test. | Paired t-test | 0.5703 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 1: analysis was performed using paired t-test. | Paired t-test | 0.5684 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 2: analysis was performed using paired t-test. | Paired t-test | 0.8235 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 2: analysis was performed using paired t-test. | Paired t-test | 0.2384 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 2: analysis was performed using paired t-test. | Paired t-test | 0.1634 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 2: analysis was performed using paired t-test. | Paired t-test | 0.7816 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 3: analysis was performed using paired t-test. | Paired t-test | 0.3917 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 3: analysis was performed using paired t-test. | Paired t-test | 0.1749 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 3: analysis was performed using paired t-test. | Paired t-test | <0.001 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 3: analysis was performed using paired t-test. | Paired t-test | 0.0905 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 4: analysis was performed using paired t-test. | Paired t-test | 0.3766 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 4: analysis was performed using paired t-test. | Paired t-test | 0.0253 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 4: analysis was performed using paired t-test. | Paired t-test | 0.0209 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 4: analysis was performed using paired t-test. | Paired t-test | 0.8206 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 5: analysis was performed using paired t-test. | Paired t-test | 0.0907 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 5: analysis was performed using paired t-test. | Paired t-test | 0.0177 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 5: analysis was performed using paired t-test. | Paired t-test | 0.0050 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 5: analysis was performed using paired t-test. | Paired t-test | 0.3724 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 6: analysis was performed using paired t-test. | Paired t-test | 0.2796 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 6: analysis was performed using paired t-test. | Paired t-test | 0.0066 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 6: analysis was performed using paired t-test. | Paired t-test | 0.0081 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 6: analysis was performed using paired t-test. | Paired t-test | 0.7853 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 7: analysis was performed using paired t-test. | Paired t-test | 0.0039 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 7: analysis was performed using paired t-test. | Paired t-test | 0.3057 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 7: analysis was performed using paired t-test. | Paired t-test | 0.3374 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 7: analysis was performed using paired t-test. | Paired t-test | 0.1410 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 8: analysis was performed using paired t-test. | Paired t-test | 0.0017 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 8: analysis was performed using paired t-test. | Paired t-test | 0.0677 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 8: analysis was performed using paired t-test. | Paired t-test | 0.1608 | 2-Sided | No | Superiority or Other |
| Change from baseline to Month 8: analysis was performed using paired t-test. | Paired t-test | 0.0196 | 2-Sided | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Baseline to Month 1: Not Done (n=81) |
|
| Month 1 to Month 2: Increase (n=75) |
|
| Month 1 to Month 2: No Change (n=75) |
|
| Month 1 to Month 2: Decrease (n=75) |
|
| Month 1 to Month 2: Not Done (n=75) |
|
| Months 2 to 3: Increase (n=72) |
|
| Months 2 to 3: No Change (n=72) |
|
| Months 2 to 3: Decrease (n=72) |
|
| Months 2 to 3: Not Done (n=72) |
|
| Months 3 to 4: Increase (n=68) |
|
| Months 3 to 4: No Change (n=68) |
|
| Months 3 to 4: Decrease (n=68) |
|
| Months 3 to 4: Not Done (n=68) |
|
| Months 4 to 5: Increase (n=67) |
|
| Months 4 to 5: No Change (n=67) |
|
| Months 4 to 5: Decrease (n=67) |
|
| Months 4 to 5: Not Done (n=67) |
|
| Months 5 to 6: Increase (n=66) |
|
| Months 5 to 6: No Change (n=66) |
|
| Months 5 to 6: Decrease (n=66) |
|
| Months 5 to 6: Not Done (n=66) |
|
| Months 6 to 7: Increase (n=64) |
|
| Months 6 to 7: No Change (n=64) |
|
| Months 6 to 7: Decrease (n=64) |
|
| Months 6 to 7: Not Done (n=64) |
|
| Months 7 to 8: Increase (n=64) |
|
| Months 7 to 8: No Change (n=64) |
|
| Months 7 to 8: Decrease (n=64) |
|
| Months 7 to 8: Not Done (n=64) |
|