An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia
13 giugno 2017 aggiornato da: Hoffmann-La Roche
Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice
This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia.
Eligible patients will be followed for 24 weeks.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
127
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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Ahmedabad, India, 380005
- Ahmedabad Dialysis Centre
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Guwahati, India, 781007
- Excel Center
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Kolkata, India, 600054
- ESIS Hospital; Department of Nephrology
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Mumbai, India, 400083
- Vertex Hospital
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New Delhi, India, 110076
- Apollo Indraprastha Hospitals; Nephrology
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Pune, India, 411033
- Aditya Birla Memorial Hospital
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Delhi
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New Delhi, Delhi, India, 110060
- Sir Gangaram Hospital
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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
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia
Descrizione
Inclusion Criteria:
- Adult patients, 18 to 65 years of age, inclusive
- Patients with chronic kidney disease on dialysis
- ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
- Adequate irons status as judged by the treating physician
Exclusion Criteria:
- Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- Clinically significant concomitant disease or disorder as defined by protocol
- Clinical suspicion of pure red cell aplasia (PRCA)
- Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
- Transfusion of red blood cells in the previous 2 months
- Pregnant women
- Contraindications for Mircera according to local prescribing information or as judged by the investigator
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
Coorti e interventi
Gruppo / Coorte |
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Coorte
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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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Mean Age of Participants Treated With C.E.R.A
Lasso di tempo: Baseline (Week 0)
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Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25
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Baseline (Week 0)
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Mean Weight of Participants Treated With C.E.R.A
Lasso di tempo: Baseline (Week 0)
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Weight of the participants was measured at the Baseline and summarized with descriptive statistics.
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Baseline (Week 0)
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Number of Participants With Co-morbidity Treated With C.E.R.A
Lasso di tempo: Up to Week 24
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Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases.
Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.
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Up to Week 24
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Mean Time Required to Achieve Target Hemoglobin Range
Lasso di tempo: Up to Week 24
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The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL).
Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1
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Up to Week 24
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Percentage of Participants Achieved Target Range of Hemoglobin
Lasso di tempo: Up to Week 24
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The target range of Hb was 10-12 gram/deciliter (g/dL).
Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1.
The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.
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Up to Week 24
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Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.
Lasso di tempo: Up to Week 24
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Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.
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Up to Week 24
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study
Lasso di tempo: Up to Week 24
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For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.
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Up to Week 24
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Mean Time Spent by Participants in the Hb Target Range
Lasso di tempo: Up to Week 24
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Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range.
The target Hb range in the study was 10-12 g/dL.
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Up to Week 24
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Evaluation of Route of Administration for C.E.R.A
Lasso di tempo: Up to Week 24
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C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration.
The frequency (number of injections) for both of these routes of administration used in the study was reported.
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Up to Week 24
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Evaluation of Dose Per Injection of C.E.R.A
Lasso di tempo: Up to Week 24
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The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information.
Mean dose per injection of C.E.R.A received by participants was reported.
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Up to Week 24
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Number of Participants Received Concomitant Medications
Lasso di tempo: Up to Week 24
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Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications.
The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine.
Participants treated with the each of these concomitant medications were reported.
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Up to Week 24
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 (Effettivo)
30 aprile 2011
Completamento primario (Effettivo)
30 settembre 2013
Completamento dello studio (Effettivo)
30 settembre 2013
Date di iscrizione allo studio
Primo inviato
30 agosto 2012
Primo inviato che soddisfa i criteri di controllo qualità
30 agosto 2012
Primo Inserito (Stima)
3 settembre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 luglio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 giugno 2017
Ultimo verificato
1 maggio 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ML25475
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 .