MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal Anemia
19. května 2016 aktualizováno: Hoffmann-La Roche
A Single Arm, Open Label, Interventional Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Hemoglobin Levels in Hemodialysis Patients With Chronic Renal Anemia
This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia.
Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent [ESA] dose administered on Week -1).
Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter [g/dL] for Switzerland and 10 to 12 g/dL for Austria).
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
120
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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Bregenz, Rakousko, 6900
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Feldkirch, Rakousko, 6807
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Graz, Rakousko, 8020
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Kufstein, Rakousko, 6330
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Linz, Rakousko, 4020
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Salzburg, Rakousko, 5020
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St Pölten, Rakousko, 3100
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Steyr, Rakousko, 4400
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Wien, Rakousko, 1030
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Wien, Rakousko, 1100
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Wien, Rakousko, 1130
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Wien, Rakousko, 1160
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Wien, Rakousko, 1220
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Basel, Švýcarsko, 4031
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Bellinzona, Švýcarsko, 6500
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Burgdorf, Švýcarsko, 3400
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Geneve, Švýcarsko, 1205
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Lausanne, Švýcarsko, 1011
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Liestal, Švýcarsko, 4410
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Locarno, Švýcarsko, 6600
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Lugano, Švýcarsko, 6903
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Luzern, Švýcarsko, 6004
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Mendrisio, Švýcarsko, 6850
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Sion, Švýcarsko, 1951
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St. Gallen, Švýcarsko, 9007
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Zürich, Švýcarsko, 8037
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Zürich, Švýcarsko, 8091
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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
- Hemoglobin concentration in country-specific target range (Switzerland: 11 to 13 g/dL; Austria: 10 to 12 g/dL)
- Regular long-term hemodialysis therapy with the same mode of dialysis for ≥3 months
- Continuous intravenous or subcutaneous maintenance ESA treatment during previous 2 months
Exclusion Criteria:
- Transfusion of red blood cells during previous 2 months
- Significant acute or chronic bleeding, such as overt gastrointestinal bleeding
- Active malignant disease (except non-melanoma skin cancer)
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 will receive intravenous Mircera every 4 weeks for a total of 52 weeks in this single-arm study.
The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.
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Mircera will be administered intravenously every 4 weeks for a total of 52 weeks.
The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.
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 or Within Target Range During the Efficacy Evaluation Period (EEP)
Časové okno: At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 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 0).
During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA.
Sampling was also performed prior to each dialysis session.
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 country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) 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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At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 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, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 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 0).
During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA.
Sampling was also performed prior to each dialysis session.
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, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24
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Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP)
Časové okno: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
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During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA.
Sampling was also performed prior to each dialysis session.
Time spent in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) 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) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
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Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP
Časové okno: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24
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During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA.
Sampling was also performed prior to each dialysis session.
The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was determined.
The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.
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Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24
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Percentage of Hb Values Above or Below the Target Range During the LTSP
Časové okno: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
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During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA.
Sampling was also performed prior to each dialysis session.
The percentage of all Hb values outside of the country-specific target range was determined and reported separately as Hb values above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and Hb values below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).
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Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
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Mean Time Spent Above or Below the Target Range for Hb During the LTSP
Časové okno: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
|
During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA.
Sampling was also performed prior to each dialysis session.
Time spent outside the country-specific target range was defined as time from each off-target Hb to time of next on-target Hb, as collected during the LTSP.
Time spent outside the target range was averaged among all participants and expressed in days, reported separately as time spent above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and time spent below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).
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Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
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Mean Excursions Above or Below Target Range for Hb During the LTSP
Časové okno: Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
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During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA.
Sampling was also performed prior to each dialysis session.
Deviation from the country-specific target range was calculated as [Hb value minus country-specific upper bound] for deviations above the target range and [Hb value minus country-specific lower bound] for deviations below the target range.
Deviations were averaged among all Hb values from all participants and expressed in g/dL, reported separately as mean deviation above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and mean deviation below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).
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Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48
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Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP
Časové okno: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
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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 LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria.
The mean number of months required for dose adjustment for any reason was calculated and averaged among all participants during the DTP and LTSP.
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Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
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Mean Dose of Mircera/CERA During the DTP and LTSP
Časové okno: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
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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 LTSP (Weeks 18 to 52) 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 LTSP and expressed in mcg.
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Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
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Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP
Časové okno: From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and LTSP (Weeks 18 to 52) was reported.
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From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52
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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. října 2007
Primární dokončení (Aktuální)
1. října 2009
Dokončení studie (Aktuální)
1. října 2009
Termíny zápisu do studia
První předloženo
16. října 2007
První předloženo, které splnilo kritéria kontroly kvality
16. října 2007
První zveřejněno (Odhad)
17. října 2007
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
24. června 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
19. května 2016
Naposledy ověřeno
1. května 2016
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .