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Clinical Study of Standard- vs Reduced-Dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Kidney Transplantation: A Prospective Randomized Trial

Bang, JB  | Oh, CK  | Ju, MK | Kim, SJ | Yu, HC | Lee, SH
Transplantation proceedings, 52(1). : 133-139, 2020
Journal Title
Transplantation proceedings
BACKGROUND: The lowering of calcineurin inhibitor exposure is possibly considered as the proper strategy to prevent calcineurin inhibitor-induced nephrotoxicity in kidney transplant. This clinical study was designed to compare the efficacy and tolerability of reduced-dose tacrolimus with standard-dose mycophenolate mofetil (MMF) vs standard-dose tacrolimus with reduced-dose MMF.

METHODS: A prospective, multicenter, open-label, randomized, and parallel-group clinical trial was conducted at 4 transplant centers in Korea. A total sample size was 108, and eligible patients were randomly assigned in a 1:1 ratio to either reduced-dose tacrolimus with standard-dose MMF (the study group) or standard-dose tacrolimus with reduced-dose MMF (the control group) for 6 months in de novo kidney transplant recipients. Graft function, the incidence of efficacy failure, and adverse events were compared.

RESULTS: The mean estimated glomerular filtration rate at 6 months post-transplantation was 69.83 +/- 16.68 mL/min/1.73 m(2) in the study group and 69.92 +/- 17.55 mL/min/1.73 m(2) in the control group (P > .05). The overall incidence of biopsy-proven acute rejection was 3.64% (n = 2) in the study group, compared to 3.77% (n = 2) in the control group (P > .05). There was no graft loss, death, or loss of follow-up in either group.

CONCLUSION: In conclusion, the results suggest that tacrolimus minimization with standard-dose MMF provides adequate immunosuppression with proper renal function and similar rate of incidence of acute rejection compared with the regimen including standard-dose tacrolimus with reduced-dose MMF.

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Journal Papers > School of Medicine / Graduate School of Medicine > Surgery
Ajou Authors
방, 준배  |  오, 창권  |  이, 수형
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