Safety and efficacy of conversion from Twice-daily tacrolimus to once-daily tacrolimus one month after transplantation: Randomized controlled trial in adult renal transplantation

Chang Kwon Oh, Kyu Ha Huh, Jong Soo Lee, Hong Rae Cho, Yu Seun Kim

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Purpose: The purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction. Materials and Methods: This prospective, randomized, open-label, multicenter study was conducted at three institutes. Patients in the investigational group were converted from tacrolimus twice daily to the same dose of extended-release tacrolimus once daily at 1 month post-transplantation, while patients in the control group were maintained on tacrolimus twice daily. The efficacies, safeties, and patient satisfaction for the two drugs at 6 months post-transplantation were compared. Results: Sixty patients were enrolled and randomized to the investigational group (28 of 29 patients completed the study) or the control group (26 of 31 patients completed the study). At 6 months post-transplantation, composite efficacy failure rates including the incidences of biopsy-confirmed acute rejection in the investigational and control groups were 0% and 10.7%, respectively; patient survival was 100% in each group. No difference in estimated glomerular filtration rate values were observed at 6 months post-transplantation (p=0.97). The safety and satisfaction profile (immunosuppressant therapy barrier scale) of once-daily tacrolimus was comparable with that of twice-daily tacrolimus (p=0.35). Conclusion: Conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective.

Original languageEnglish
Pages (from-to)1341-1347
Number of pages7
JournalYonsei medical journal
Volume55
Issue number5
DOIs
Publication statusPublished - 2014 Sep

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Tacrolimus
Kidney Transplantation
Randomized Controlled Trials
Transplantation
Safety
Patient Satisfaction
Control Groups
Immunosuppressive Agents
Glomerular Filtration Rate
Multicenter Studies
Biopsy
Survival
Incidence

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

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title = "Safety and efficacy of conversion from Twice-daily tacrolimus to once-daily tacrolimus one month after transplantation: Randomized controlled trial in adult renal transplantation",
abstract = "Purpose: The purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction. Materials and Methods: This prospective, randomized, open-label, multicenter study was conducted at three institutes. Patients in the investigational group were converted from tacrolimus twice daily to the same dose of extended-release tacrolimus once daily at 1 month post-transplantation, while patients in the control group were maintained on tacrolimus twice daily. The efficacies, safeties, and patient satisfaction for the two drugs at 6 months post-transplantation were compared. Results: Sixty patients were enrolled and randomized to the investigational group (28 of 29 patients completed the study) or the control group (26 of 31 patients completed the study). At 6 months post-transplantation, composite efficacy failure rates including the incidences of biopsy-confirmed acute rejection in the investigational and control groups were 0{\%} and 10.7{\%}, respectively; patient survival was 100{\%} in each group. No difference in estimated glomerular filtration rate values were observed at 6 months post-transplantation (p=0.97). The safety and satisfaction profile (immunosuppressant therapy barrier scale) of once-daily tacrolimus was comparable with that of twice-daily tacrolimus (p=0.35). Conclusion: Conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective.",
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Safety and efficacy of conversion from Twice-daily tacrolimus to once-daily tacrolimus one month after transplantation : Randomized controlled trial in adult renal transplantation. / Oh, Chang Kwon; Huh, Kyu Ha; Lee, Jong Soo; Cho, Hong Rae; Kim, Yu Seun.

In: Yonsei medical journal, Vol. 55, No. 5, 09.2014, p. 1341-1347.

Research output: Contribution to journalArticle

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AU - Lee, Jong Soo

AU - Cho, Hong Rae

AU - Kim, Yu Seun

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AB - Purpose: The purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction. Materials and Methods: This prospective, randomized, open-label, multicenter study was conducted at three institutes. Patients in the investigational group were converted from tacrolimus twice daily to the same dose of extended-release tacrolimus once daily at 1 month post-transplantation, while patients in the control group were maintained on tacrolimus twice daily. The efficacies, safeties, and patient satisfaction for the two drugs at 6 months post-transplantation were compared. Results: Sixty patients were enrolled and randomized to the investigational group (28 of 29 patients completed the study) or the control group (26 of 31 patients completed the study). At 6 months post-transplantation, composite efficacy failure rates including the incidences of biopsy-confirmed acute rejection in the investigational and control groups were 0% and 10.7%, respectively; patient survival was 100% in each group. No difference in estimated glomerular filtration rate values were observed at 6 months post-transplantation (p=0.97). The safety and satisfaction profile (immunosuppressant therapy barrier scale) of once-daily tacrolimus was comparable with that of twice-daily tacrolimus (p=0.35). Conclusion: Conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective.

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