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.
Artigo
em Coreano
| WPRIM
| ID: wpr-127068
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, 11 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)).
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Rejeição em Psicologia
/
Incidência
/
Estudos Prospectivos
/
Terapia de Imunossupressão
/
Transplante de Rim
/
Satisfação do Paciente
/
Tacrolimo
/
Complacência (Medida de Distensibilidade)
/
Taxa de Filtração Glomerular
/
Sobrevivência de Enxerto
Tipo de estudo:
Ensaio Clínico Controlado
/
Estudo de incidência
/
Estudo observacional
/
Estudo prognóstico
Limite:
Humanos
Idioma:
Coreano
Revista:
The Journal of the Korean Society for Transplantation
Ano de publicação:
2012
Tipo de documento:
Artigo
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