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This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Kidney Disease | Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of haemoglobin. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Dose of MIRCERA at Entry Level | The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported. | Baseline |
| Average Dose of MIRCERA During Titration Period Month 1 | The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported. | Month 1 |
| Average Dose of MIRCERA During Titration Period Month 2 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported. | Month 2 |
| Average Dose of MIRCERA During Titration Period Month 3 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported. | Month 3 |
| Average Dose of MIRCERA During Titration Period Month 4 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported. | Month 4 |
| Average Dose of MIRCERA During Maintenance Period Month 1 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | Month 5 (Maintenance Period Month 1) |
| Average Dose of MIRCERA During Maintenance Period Month 2 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Hemoglobin (Hb) Level During Titration Period | The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA. | Baseline, Month 1, 2, 3, 4 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic kidney disease receiving Mircera treatment
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Novy Jicin; Dialyzacni Stredisko | Nový Jičín | 741 11 | Czechia |
Study included Titration Period (4 months) and Maintenance Period (6 Months).
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Kidney Disease (CKD) | Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Titration Period (4 Months) |
| |||||||||||||
| Maintenance Period (6 Months) |
|
All enrolled participants were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Kidney Disease (CKD) | Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin. |
| 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 | Average Dose of MIRCERA at Entry Level | The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported. | All participants who received at least one dose of MIRCERA during the titration period. | Posted | Mean | Standard Deviation | microgram (µg) | Baseline |
|
|
3.5 years
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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 | Chronic Kidney Disease (CKD) | Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure left | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Month 6 (Maintenance Period Month 2) |
| Average Dose of MIRCERA During Maintenance Period Month 3 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | Month 7 (Maintenance Period Month 3) |
| Average Dose of MIRCERA During Maintenance Period Month 4 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | Month 8 (Maintenance Period Month 4) |
| Average Dose of MIRCERA During Maintenance Period Month 5 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | Month 9 (Maintenance Period Month 5) |
| Average Dose of MIRCERA During Maintenance Period Month 6 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | Month 10 (Maintenance Period Month 6) |
| The Mean Hemoglobin (Hb) Level During Maintenance Period | The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA | Month 5, 6, 7, 8, 9, 10 |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | The Mean Hemoglobin (Hb) Level During Titration Period | The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA. | All participants who received at least one dose of MIRCERA during titration period. | Posted | Mean | Standard Deviation | g/L | Baseline, Month 1, 2, 3, 4 |
|
|
|
| Secondary | The Mean Hemoglobin (Hb) Level During Maintenance Period | The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA | All participants who received at least one dose of MIRCERA during maintenance period. | Posted | Mean | Standard Deviation | g/L | Month 5, 6, 7, 8, 9, 10 |
|
|
|
| Primary | Average Dose of MIRCERA During Titration Period Month 1 | The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported. | All participants who received at least one dose of MIRCERA during titration period. | Posted | Mean | Standard Deviation | microgram (µg) | Month 1 |
|
|
|
| Primary | Average Dose of MIRCERA During Titration Period Month 2 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported. | All participants who received at least one dose of MIRCERA during titration period. | Posted | Mean | Standard Deviation | microgram (µg) | Month 2 |
|
|
|
| Primary | Average Dose of MIRCERA During Titration Period Month 3 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported. | All participants who received at least one dose of MIRCERA during titration period. | Posted | Mean | Standard Deviation | microgram (µg) | Month 3 |
|
|
|
| Primary | Average Dose of MIRCERA During Titration Period Month 4 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported. | All participants who received at least one dose of MIRCERA during titration period. | Posted | Mean | Standard Deviation | microgram (µg) | Month 4 |
|
|
|
| Primary | Average Dose of MIRCERA During Maintenance Period Month 1 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | All participants who received at least one dose of MIRCERA during the maintenance period. | Posted | Mean | Standard Deviation | microgram (µg) | Month 5 (Maintenance Period Month 1) |
|
|
|
| Primary | Average Dose of MIRCERA During Maintenance Period Month 2 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | All participants who received at least one dose of MIRCERA during the maintenance period. | Posted | Mean | Standard Deviation | microgram (µg) | Month 6 (Maintenance Period Month 2) |
|
|
|
| Primary | Average Dose of MIRCERA During Maintenance Period Month 3 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | All participants who received at least one dose of MIRCERA during the maintenance period. | Posted | Mean | Standard Deviation | microgram (µg) | Month 7 (Maintenance Period Month 3) |
|
|
|
| Primary | Average Dose of MIRCERA During Maintenance Period Month 4 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | All participants who received at least one dose of MIRCERA during the maintenance period. | Posted | Mean | Standard Deviation | microgram (µg) | Month 8 (Maintenance Period Month 4) |
|
|
|
| Primary | Average Dose of MIRCERA During Maintenance Period Month 5 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | All participants who received at least one dose of MIRCERA during the maintenance period. | Posted | Mean | Standard Deviation | microgram (µg) | Month 9 (Maintenance Period Month 5) |
|
|
|
| Primary | Average Dose of MIRCERA During Maintenance Period Month 6 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | All participants who received at least one dose of MIRCERA during the maintenance period. | Posted | Mean | Standard Deviation | microgram (µg) | Month 10 (Maintenance Period Month 6) |
|
|
|
| 5 |
| 340 |
| 2 |
| 340 |
| Sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Endocarditis infective | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Peripheral arterial disease | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Post surgical haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA 14.1 | 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.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Month 3 |
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| Month 4 |
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| Title | Measurements |
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| Month 8 |
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| Month 9 |
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| Month 10 |
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