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This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Mircera |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mircera | Drug | Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha will be observed for a period of 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study | Month 4 up to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Hb Level to 11-12 g/dL | Up to 6 months | |
| Number of Dose Adjustments Required to Maintain Hb Levels | Up to 6 months | |
| Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic kidney disease
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheikh Zayed Hospital; Department of Nephrology | Lahore | 20021 | Pakistan | |||
| Fatima Memorial Hospital; Nephrology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mircera | Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) analysis set included all participants who were enrolled in the study. Age (continuous) data were reported only for treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mircera | Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Number of participants analyzed for this baseline characteristic were 21, as the age data were available only for treated 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 | Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study | None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed. | Posted | Month 4 up to Month 6 |
|
|
Up to 6 months
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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 with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
As none of the enrolled participants in the study achieved the endpoint of maintaining Hb level between 11-12 g/dL during the final 2 months of study, therefore efficacy parameters were not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 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 |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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| Up to 6 months |
| Lahore |
| 54590 |
| Pakistan |
| Doctor's Hospital and Medical Centre | Lahore | Pakistan |
| Khair-un-Nisa Hospital | Lahore | Pakistan |
| Surgimed Hospital | Lahore | Pakistan |
| Northwest General Hospital; Department of Nephrology | Peshawar | Pakistan |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Time to Achieve Hb Level to 11-12 g/dL | None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed. | Posted | Up to 6 months |
|
|
| Secondary | Number of Dose Adjustments Required to Maintain Hb Levels | None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed. | Posted | Up to 6 months |
|
|
| Secondary | Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC) | The number of doses were not collected because the participants never achieved Hb level of 11 to 12 g/dL. | Posted | Up to 6 months |
|
|
| 3 |
| 22 |
| 11 |
| 22 |
| Nausea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 18.0 | 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.