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
in Korean
| 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)).
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Rejection, Psychology
/
Incidence
/
Prospective Studies
/
Immunosuppression Therapy
/
Kidney Transplantation
/
Patient Satisfaction
/
Tacrolimus
/
Compliance
/
Glomerular Filtration Rate
/
Graft Survival
Type of study:
Controlled clinical trial
/
Incidence study
/
Observational study
/
Prognostic study
Limits:
Humans
Language:
Korean
Journal:
The Journal of the Korean Society for Transplantation
Year:
2012
Type:
Article
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