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- Klinische Studie NCT01051323
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia
17. November 2015 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
1580
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Saarlouis, Deutschland, 66740
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
CKD patients treated with Mirecera at different medical centers
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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1
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As prescribed by physician
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2010
Primärer Abschluss (Tatsächlich)
1. Februar 2013
Studienabschluss (Tatsächlich)
1. Februar 2013
Studienanmeldedaten
Zuerst eingereicht
15. Januar 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. Januar 2010
Zuerst gepostet (Schätzen)
18. Januar 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
18. Dezember 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. November 2015
Zuletzt verifiziert
1. November 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ML22714
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