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This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving once monthly Mircera according to standard of care and local labelling during 12 months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Levels | Baseline; Weeks 8, 16, 24, 48 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic renal anemia on haemodialysis in maintenance ESA treatment
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delcevo | 2320 | North Macedonia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Mircera | Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Prilep |
| 7500 |
| North Macedonia |
| Shtip | 2000 | North Macedonia |
| Skopje | 1000 | North Macedonia |
| Struga | 6000 | North Macedonia |
| Strumica | 2400 | North Macedonia |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Safety population included all treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mircera | Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Number of Participants With Adverse Events (AEs) | AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs. | Safety population | Posted | Number | participants | Up to 12 months |
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| Secondary | Hemoglobin Levels | Efficacy intent-to-treat population included all treated participants. Here, 'n' signifies the number of participants with available data for hemoglobin at specified visits. | Posted | Mean | Standard Deviation | gram per liter | Baseline; Weeks 8, 16, 24, 48 |
|
|
Up to 12 months
Safety population.
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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® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling. | 22 | 184 | 14 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased hemoglobin | Blood and lymphatic system disorders | MedDRA 4.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 4.0 | Non-systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | MedDRA 4.0 | Non-systematic Assessment |
| |
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | MedDRA 4.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 4.0 | Non-systematic Assessment |
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| Death | General disorders | MedDRA 4.0 | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 4.0 | Non-systematic Assessment |
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| Vascular access thrombosis | Injury, poisoning and procedural complications | MedDRA 4.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | Non-systematic Assessment |
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| Hematuria | Renal and urinary disorders | MedDRA 4.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Non-systematic Assessment |
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| Epistaxis with melena | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA 4.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D007674 | Kidney Diseases |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline (n=184) |
| |||||
| Week 8 (n=179) |
| |||||
| Week 16 (n=155) |
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| Week 24 (n=161) |
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| Week 48 (n=130) |
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