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This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL) | Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL | Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment. | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with renal anemia on treatment with Mircera
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Timios Stavros Clinic; Nephrology Department | Aigáleo | 12244 | Greece | |||
| General Hospital of Artas; Nephrology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methoxy-Polyethylene-Glycol-Epoetin Beta | Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) according to the standard clinical practice, were observed for at least 6 months in this retrospective study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Arta |
| 47100 |
| Greece |
| Pantokrator Private Clinic; Nephrology | Athens | 10433 | Greece |
| Attikon Center; Nephrology | Athens | 11362 | Greece |
| Athinaiki Private Clinic | Athens | 11521 | Greece |
| Kyanos Stavros Private Hospital; Nephrologic Clinic | Athens | 11528 | Greece |
| Iaso General Private Clinic; Nephrology | Athens | 15562 | Greece |
| Iatriko Athinon Clinic Dafnis; Nephrology Department | Daphni-athens | 17237 | Greece |
| Kyanous Stavros of Patras, Renal Disease Therapy Unit | Pátrai | 26225 | Greece |
| Olympion Therapeytirion; Nefrology | Pátrai | 26443 | Greece |
| Iasis Private Clinic | Piraeus | 42356 | Greece |
| General Hospital Of Chalkidikis; Dialysis Center Unit | Polygyros | 63100 | Greece |
| Diavalkaniko Kentro; Nephrology | Thessaloniki | 57001 | Greece |
| General Hospital of Thessalonikis G.Papanikolaou; Nephrology | Thessaloniki | 57010 | Greece |
| Alfa Nefrodynamiki; Nefrology | Thessaloniki | 57500 | Greece |
| Thessaliki Nossileytiki; Nephrology | Volos | 38221 | Greece |
| General Hospital of Volos; Nephrology | Volos | 38222 | Greece |
| COMPLETED |
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| NOT COMPLETED |
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Baseline population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Methoxy-Polyethylene-Glycol-Epoetin Beta | Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Here, 773 participants were analyzed for this baseline measure (age). Since this is a non-interventional retrospective study participants with missing data were excluded from the analysis. | Mean | Standard Deviation | Years |
| |||||||||||||||||||||
| Sex/Gender, Customized | Number | Participants |
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| 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 Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL) | Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment. | Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome. | Posted | Number | Percentage of participants | Up to 6 months |
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| Secondary | Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL | Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment. | Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome. | Posted | Number | Percentage of participants | Up to 6 months |
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This was a retrospective study, so the adverse events have already been reported according to the current pharmacovigilance regulations. In addition, this study did not aim to evaluate the safety of methoxy-polyethylene glycol-epoetin beta.
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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 | Methoxy-Polyethylene-Glycol-Epoetin Beta | Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study. | 0 | 0 | 0 | 0 |
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The Study being conducted under this Agreement is part of the Overall Study. Investigators is free to publish in reputed 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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| Missing |
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