A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis
16. Februar 2016 aktualisiert von: Hoffmann-La Roche
A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary.
Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
124
Phase
- Phase 3
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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-
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Baja, Ungarn, 6500
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Budapest, Ungarn, 1062
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Debrecen, Ungarn, 4032
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Esztergom, Ungarn, 2500
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Keszthely, Ungarn, 8360
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Miskolc, Ungarn, 3526
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Salgótarján, Ungarn, 3100
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Szolnok, Ungarn, 5000
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VAC, Ungarn, 2600
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Zalaegerszeg, Ungarn, 8900
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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
Beschreibung
Inclusion Criteria:
- Adults greater than or equal to (≥) 18 years of age
- Chronic renal anemia
- Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
- Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months
Exclusion Criteria:
- Transfusion of red blood cells during previous 2 months
- Poorly controlled hypertension
- Significant acute or chronic bleeding
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Mircera in Renal Anemia
Participants with chronic renal anemia previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study.
The first dose will be determined by the dose of ESA received prior to administration of study treatment, and subsequent doses will be adjusted to achieve target Hb concentrations.
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Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy.
Treatment will continue for 52 weeks.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)
Zeitfenster: Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1).
During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera.
The average Hb during the EEP was calculated per participant and assessed against the reference value.
The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint.
The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
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Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Mean Change in Time-Adjusted Hb From Baseline to EEP
Zeitfenster: At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1).
During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera.
The average Hb during the EEP was calculated per participant and assessed against the reference value.
The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL.
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At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP
Zeitfenster: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera.
The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined.
The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.
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Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Mean Time Spent in the Target Range for Hb During the EEP
Zeitfenster: Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
|
During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera.
Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP.
Time spent in the target range was averaged among all participants and expressed in days.
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Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
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Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP
Zeitfenster: Weeks 0, 4, 8, 12, 16, 20, and 24
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Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1.
Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria.
The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg.
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Weeks 0, 4, 8, 12, 16, 20, and 24
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Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP
Zeitfenster: Weeks 0, 4, 8, 12, 16, 20, and 24
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Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1.
Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria.
The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.
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Weeks 0, 4, 8, 12, 16, 20, and 24
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Number of Participants Receiving Blood Transfusion During the DTP and EEP
Zeitfenster: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24
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The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.
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Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24
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Number of Blood Transfusions During the DTP and EEP
Zeitfenster: Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24
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The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.
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Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24
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Mitarbeiter und Ermittler
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Studienaufzeichnungsdaten
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Haupttermine studieren
Studienbeginn
1. August 2008
Primärer Abschluss (Tatsächlich)
1. November 2010
Studienabschluss (Tatsächlich)
1. November 2010
Studienanmeldedaten
Zuerst eingereicht
16. April 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. April 2008
Zuerst gepostet (Schätzen)
17. April 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
15. März 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Februar 2016
Zuletzt verifiziert
1. Februar 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ML20752
- 2006-005621-28
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