An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia
17. listopadu 2015 aktualizováno: Hoffmann-La Roche
Non-interventional Study to Investigate Hemoglobin Levels and Dose Over Time in the Daily Use of Mircera for Renal Anemia in Larger Centers, and to Detect Differences Between Standard of Care in the Centers
This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers.
Data from each patient will be collected over 12 months of Mircera therapy.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Pozorovací
Zápis (Aktuální)
1580
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Saarlouis, Německo, 66740
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
CKD patients treated with Mirecera at different medical centers
Popis
Inclusion Criteria:
- adult patients, >/= 18 years of age
- chronic kidney disease
- informed consent for data transmission
Exclusion Criteria:
- serious hematological or infectious disease
- acute bleeding in the 16 weeks preceding data collection
- participation in an interventional trial
- female patients: pregnancy or breast-feeding
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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1
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As prescribed by physician
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range
Časové okno: Month 0 to Month 12
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Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12).
The target hemoglobin range was 10 to 13 gram/deciliter (g/dL).
Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.
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Month 0 to Month 12
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Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Časové okno: Month 0 to Month 12
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The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented.
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Month 0 to Month 12
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Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Časové okno: Month 6 to Month 12
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The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented.
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Month 6 to Month 12
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Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
Časové okno: Month 0 to Month 12
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For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values.
Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented.
Data for this outcome measure was reported for overall participants.
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Month 0 to Month 12
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Serum Ferritin Values
Časové okno: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Serum ferritin levels were measured as nanogram/milliliter (ng/mL).
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Serum Iron Values
Časové okno: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Serum iron levels were measured as microgram/deciliter (mcg/dL).
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Transferrin Values
Časové okno: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Transferrin levels were measured as milligram/deciliter (mg/dL).
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Transferrin Saturation Values
Časové okno: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test.
It is the ratio of serum iron and total iron-binding capacity, multiplied by 100.
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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C-reactive Protein (CRP) Values
Časové okno: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay.
A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Number of Physicians Satisfied With Treatment at Final Visit
Časové okno: Month 12 or early discontinuation
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Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit.
Physicians' responses were "very satisfied", "satisfied", "undecided", or "not satisfied".
One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed.
Data for this outcome measure was reported for overall participants.
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Month 12 or early discontinuation
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Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion
Časové okno: Month 12 or early discontinuation
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At final visit, physicians were asked to answer ("yes" or "no") the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion.
Data for this outcome measure was reported for overall participants.
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Month 12 or early discontinuation
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Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Časové okno: Month 12 or early discontinuation
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At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta.
The same participant could have discontinued treatment due to multiple reasons.
Data for this outcome measure was reported for overall participants.
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Month 12 or early discontinuation
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Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Časové okno: Month 12 or early discontinuation
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Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented.
Data for this outcome measure was reported for overall participants.
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Month 12 or early discontinuation
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Number of Participants Satisfied With Treatment at Final Visit
Časové okno: Month 12 or early discontinuation
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Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit.
Participants' responses were "very satisfied", "satisfied", "undecided", or "not satisfied".
Data for this outcome measure was reported for overall participants.
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Month 12 or early discontinuation
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Časové okno: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month.
Mean values were taken when more than 1 application was documented for a participant during the time period considered.
Data for this outcome measure was reported for overall participants.
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Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2010
Primární dokončení (Aktuální)
1. února 2013
Dokončení studie (Aktuální)
1. února 2013
Termíny zápisu do studia
První předloženo
15. ledna 2010
První předloženo, které splnilo kritéria kontroly kvality
15. ledna 2010
První zveřejněno (Odhad)
18. ledna 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
18. prosince 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. listopadu 2015
Naposledy ověřeno
1. listopadu 2015
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ML22714
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