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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

 Jun Bae Bang  ;  Chang-Kwon Oh  ;  Man Ki Ju  ;  Sung Joo Kim  ;  Hee Chul Yu  ;  Su Hyung Lee 
 TRANSPLANTATION PROCEEDINGS, Vol.52(1) : 133-139, 2020-01 
Journal Title
Issue Date
Adult ; Drug Therapy, Combination ; Drugs, Generic ; Female ; Glomerular Filtration Rate ; Graft Rejection / epidemiology ; Graft Rejection / prevention & control* ; Humans ; Immunosuppression Therapy ; Immunosuppressive Agents / administration & dosage* ; Incidence ; Kidney Transplantation* ; Male ; Middle Aged ; Mycophenolic Acid / administration & dosage* ; Prospective Studies ; Republic of Korea / epidemiology ; Tacrolimus / administration & dosage* ; Treatment Outcome
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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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Joo, Man Ki(주만기) ORCID logo https://orcid.org/0000-0002-4112-7003
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