STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients
17. maj 2016 opdateret af: 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, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia.
Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration.
The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
188
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Brno, Tjekkiet, 656 91
-
Cesky Krumlov, Tjekkiet, 38127
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Decin, Tjekkiet, 405 99
-
Havirov, Tjekkiet, 736 24
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Hradec Kralove, Tjekkiet, 500 05
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Jihlava, Tjekkiet, 586 33
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Karlovy Vary, Tjekkiet, 360 73
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Kolin Iii, Tjekkiet, 280 20
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Liberec, Tjekkiet, 460 63
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Novy Jicin, Tjekkiet, 741 11
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Olomouc, Tjekkiet, 775 20
-
Ostrava, Tjekkiet, 708 52
-
Pisek, Tjekkiet, 397 23
-
Praha, Tjekkiet, 150 30
-
Praha, Tjekkiet, 128 08
-
Praha, Tjekkiet, 14000
-
Praha 6, Tjekkiet, 169 00
-
Strakonice, Tjekkiet, 38629
-
Sumperk, Tjekkiet, 787 01
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Tabor, Tjekkiet, 390 03
-
Teplice, Tjekkiet, 415 01
-
Trebic, Tjekkiet, 674 01
-
Usti Nad Labem, Tjekkiet, 401 13
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Znojmo, Tjekkiet, 76275
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Chronic renal anemia;
- Continuous stable intravenous maintenance epoetin therapy during previous month;
- Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.
Exclusion Criteria:
- Transfusion of red blood cells during previous 2 months;
- Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
- Significant acute or chronic bleeding.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
|
120, 200 eller 360 mikrogram iv månedligt (startdosis)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
Tidsramme: Week 17 up to Week 24
|
Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP).
The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.
|
Week 17 up to Week 24
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Hemoglobin Concentration Between Reference (SVP) and EEP
Tidsramme: Week -4 up to Week -1 and Week 17 up to Week 24
|
The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.
|
Week -4 up to Week -1 and Week 17 up to Week 24
|
|
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
Tidsramme: Week 17 up to Week 24
|
Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.
|
Week 17 up to Week 24
|
|
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Tidsramme: Week 17 up to Week 24
|
Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.
|
Week 17 up to Week 24
|
|
Percentage of Participants Requiring Any Dose Adjustment
Tidsramme: Week 1 to Week 16 and Week 17 to Week 24
|
Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.
|
Week 1 to Week 16 and Week 17 to Week 24
|
|
Number of Participants With Red Blood Cell Transfusion During the Study
Tidsramme: Week -4 up to Week 28
|
Number of participant who underwent red blood cell transfusion during the study was reported.
|
Week -4 up to Week 28
|
|
Number of Participants With Anti-epoetin Antibody
Tidsramme: Week -4 and at early withdrawal or Week 28
|
Week -4 and at early withdrawal or Week 28
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2007
Primær færdiggørelse (Faktiske)
1. juli 2009
Studieafslutning (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først indsendt
19. marts 2008
Først indsendt, der opfyldte QC-kriterier
19. marts 2008
Først opslået (Skøn)
25. marts 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. juni 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. maj 2016
Sidst verificeret
1. maj 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ML21040
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .