A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis
16 febbraio 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
124
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Baja, Ungheria, 6500
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Budapest, Ungheria, 1062
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Debrecen, Ungheria, 4032
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Esztergom, Ungheria, 2500
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Keszthely, Ungheria, 8360
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Miskolc, Ungheria, 3526
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Salgótarján, Ungheria, 3100
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Szolnok, Ungheria, 5000
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VAC, Ungheria, 2600
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Zalaegerszeg, Ungheria, 8900
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mean Change in Time-Adjusted Hb From Baseline to EEP
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2008
Completamento primario (Effettivo)
1 novembre 2010
Completamento dello studio (Effettivo)
1 novembre 2010
Date di iscrizione allo studio
Primo inviato
16 aprile 2008
Primo inviato che soddisfa i criteri di controllo qualità
16 aprile 2008
Primo Inserito (Stima)
17 aprile 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
15 marzo 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 febbraio 2016
Ultimo verificato
1 febbraio 2016
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ML20752
- 2006-005621-28
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .