Multicenter Clinical Investigation for the Safety and Efficacy of Advagraf(R) (Extended Release Tacrolimus) versus Prograf(R) (Tacrolimus) in De Novo Kidney Recipients after 1 Month of Transplantation: Preliminary Results / 대한이식학회지
The Journal of the Korean Society for Transplantation
; : 254-260, 2012.
Article
en Ko
| WPRIM
| ID: wpr-127068
Biblioteca responsable:
WPRO
ABSTRACT
BACKGROUND: Compliance from kidney transplant recipients might improve with less frequent doses of immunosuppressant drugs. We describe the development of an extended-release formulation of tacrolimus that enables taking the drug just once a day, instead of the current twice a day tacrolimus formulation. METHODS: We performed a prospective, open-label, 1:1 randomized, and multicenter study. Patients received Prograf(R) (Astellas Inc.) twice a day for 1 month post-transplantation. The patients of the investigational group converted to a dose of Advagraf(R) (Astellas Inc.) given once a day. We evaluated the efficacy, safety, and patient satisfaction of both groups. RESULTS: Within 5 months after conversion to Advagraf, the incidence of biopsy-confirmed acute rejection was 0%, while patient and graft survival was 100%. We could not find differences of the patients' estimated glomerular filtration rate (eGFR) between the Prograf and Advagraf treated groups 1~6 months post-transplantation. The safety profile and satisfaction profiles (immunosuppressant therapy barrier scale) were also equivalent between the treated groups. CONCLUSIONS: The preliminary results of this study support the safety, efficacy, and patient satisfaction from a single daily formulation of tacrolimus (Advagraf(R)).
Palabras clave
Texto completo:
1
Base de datos:
WPRIM
Asunto principal:
Rechazo en Psicología
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Incidencia
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Estudios Prospectivos
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Terapia de Inmunosupresión
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Trasplante de Riñón
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Satisfacción del Paciente
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Tacrolimus
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Adaptabilidad
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Tasa de Filtración Glomerular
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Supervivencia de Injerto
Tipo de estudio:
Clinical_trials
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Incidence_studies
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Observational_studies
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Prognostic_studies
Límite:
Humans
Idioma:
Ko
Revista:
The Journal of the Korean Society for Transplantation
Año:
2012
Tipo del documento:
Article