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This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Hemoglobin Cycling | Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (>=) 1.5 gram per deciliter (g/dL) and a duration >=8 weeks. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Full Hemoglobin Cycles Per Participant | Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks. | 9 months |
| Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic kidney disease patients with anemia treated 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 | Mircera | Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks. |
| 9 months |
| Arta |
| 47100 |
| Greece |
| Attikon Center; Nephrology | Athens | 11362 | Greece |
| Athinaiki Private Clinic | Athens | 11521 | Greece |
| Hospital henry dunant; Nephrology | Athens | 11526 | Greece |
| General Hospital Hippokration of Athens; Nephrology | Athens | 11527 | Greece |
| General Hospital Of Athens G.Gennimatas; Nephrology | Athens | 11527 | Greece |
| Kyanos Stavros Private Hospital; Nephrologic Clinic | Athens | 11528 | Greece |
| General Hospital Of West Attikis; Nephrology | Athens | 12351 | Greece |
| University Hospital Attikon ; Pathology Clinic | Athens | 124 61 | Greece |
| General Hospital Agia Olga; Nephrology | Athens | 14233 | Greece |
| Iaso General Private Clinic; Nephrology | Athens | 15562 | Greece |
| Iatriko Athinon Clinic Dafnis; Nephrology Department | Daphni-athens | 17237 | Greece |
| General Hospital Of Dramas; Dialysis Center Unit | Drama | 66100 | Greece |
| University Hospital Of Heraklion; Nefrologiki Clinic | Heraklion | 71110 | Greece |
| General Hospital Of Katerinis; Nephrology Unit | Katerini | Greece |
| General Hospital Of Lamias; Nephrology | Lamia | 35100 | Greece |
| Univeristy Hospital of Larissa; Nephrology | Larissa | 41 110 | Greece |
| Eytychios Patsidis Center Of Haemodialysis | Larissa | 41335 | Greece |
| General Hospital Of Leykadas; Dialysis Center Unit | Leykada | 31100 | Greece |
| Leivadia General Hospital; Nephrologic Clinic | Livadeia | 32100 | Greece |
| Kyanous Stavros of Patras, Renal Disease Therapy Unit | Pátrai | 26225 | Greece |
| Olympion Therapeytirion; Nefrology | Pátrai | 26443 | Greece |
| General Hospital Tzanio ; Nephrology | Piraeus | 18536 | Greece |
| General Hospital Of Chalkidikis; Dialysis Center Unit | Polygyros | 63100 | Greece |
| Rodos General Hospital; Nephrologic Clinic | Rhodes | 85100 | Greece |
| Alpha Nephrodynamiki Of Serres; Dialysis Center Unit | Serres | Greece |
| Ahepa Hospital; 1St Dept. of Medicine | Thessaloniki | 54636 | Greece |
| IPPOKRATES Private Dialysis Centre | Thessaloniki | 54643 | Greece |
| General Hospital Of Thessalonikis Papageorgiou; Nephrology | Thessaloniki | 56403 | Greece |
| Alfa Nefrodynamiki; Nefrology | Thessaloniki | 57500 | Greece |
| Thessaliki Nossileytiki; Nephrology | Volos | 38221 | Greece |
| General Hospital of Volos; Nephrology | Volos | 38222 | Greece |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis population included all treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mircera | Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data for this baseline characteristic were available for 1276 participants only. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 With at Least One Hemoglobin Cycling | Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (>=) 1.5 gram per deciliter (g/dL) and a duration >=8 weeks. | Analysis population included all treated participants. | Posted | Number | percentage of participants | 9 months |
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| Secondary | Number of Full Hemoglobin Cycles Per Participant | Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks. | Analysis population included all treated participants. | Posted | Mean | Standard Deviation | cycles | 9 months |
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| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling | Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks. | Analysis population included all treated participants. 'N' (number of participants analyzed) included those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | 9 months |
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Due to 'retrospective' nature of this registry data study, it was not possible to collect complete adverse events (AE) data. Hence, it was planned not to collect any AE data in this study.
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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 renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files. | 0 | 0 | 0 | 0 |
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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 |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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