A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis
16. února 2016 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
124
Fáze
- Fáze 3
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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Baja, Maďarsko, 6500
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Budapest, Maďarsko, 1062
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Debrecen, Maďarsko, 4032
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Esztergom, Maďarsko, 2500
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Keszthely, Maďarsko, 8360
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Miskolc, Maďarsko, 3526
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Salgótarján, Maďarsko, 3100
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Szolnok, Maďarsko, 5000
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VAC, Maďarsko, 2600
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Zalaegerszeg, Maďarsko, 8900
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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
Popis
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
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
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean Change in Time-Adjusted Hb From Baseline to EEP
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
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. srpna 2008
Primární dokončení (Aktuální)
1. listopadu 2010
Dokončení studie (Aktuální)
1. listopadu 2010
Termíny zápisu do studia
První předloženo
16. dubna 2008
První předloženo, které splnilo kritéria kontroly kvality
16. dubna 2008
První zveřejněno (Odhad)
17. dubna 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
15. března 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. února 2016
Naposledy ověřeno
1. února 2016
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ML20752
- 2006-005621-28
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