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Low-dose Mycophenolate Mofetil in Tablet or Capsule Form Combined With Tacrolimus in the Early Period after Kidney Transplantation: a prospective randomized trial

Lee, Su Hyung1; Kim, Chan-Duck2; Cho, Baik-Hwan3; Ju, Man Ki4; Lee, Dong Ryeol5; Park, Jong-Won6; Lee, Jung Jun7; Lee, Samuel8; So, Byung Jun9; Oh, Chang-Kwon1; Kim, Yu Seun10

doi: 10.1097/

1Surgery, Ajou University School of Medicine, Suwon, Korea; 2Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea, Daegu, Korea; 3Surgery, Chonbuk National University Medical School, Jeonju, Korea; 4Surgery, Gangnam Severance Hospital, Yonsei University Health System, Seoul, Korea; 5Internal Medicine, Maryknoll Medical Center, Busan, Korea; 6Internal Medicine, Yeungnam University Medical Center, Daegu, Korea; 7Surgery, CHA Bundang Medical Center, CHA University, Bundang, Korea; 8Surgery, Hallym University College of Medicine, Seoul, Korea; 9Surgery, Wonkwang University School of Medicine, Iksan, Korea; 10Surgery, Yonsei University College of Medicine, Seoul, Korea.

Aims: Mycophenolate mofetil (MMF) has been used as an important constituent of low toxicity, calcineurin inhibitor sparing immunosuppression. We examined the efficacy and safety of MMF according to its different forms combined with tacrolimus in kidney transplant recipients.

Methods: This multicenter, 26-week, randomized trial was performed to compare the efficacy and safety of the tablet form of MMF versus the capsule form of MMF in 156 kidney transplant recipients. Allograft function, the incidence of efficacy failure [biopsy-proven acute rejection (BPAR), death, graft loss, or loss to follow-up], and adverse events were compared.

Results: The mean dose of MMF at 26 weeks was comparable: 1052.6 ± 194.2 mg/day in the tablet group vs. 1155.6 ± 298.1 mg/day in the capsule group (P = 0.063). Trough levels of tacrolimus at 26 weeks were comparable. The mean estimated glomerular filtration rate of the tablet group at 26 weeks post-transplant was non-inferior to that of the capsule. The incidence of efficacy failure was similar in the two groups: tablet group, 5.2% and capsule group, 7.7% (difference −2.5%; 95% confidence interval −5.22% to 10.21%). The incidence of BPAR until 26 weeks post-transplant in the tablet group was 3.9%, compared to 7.7% in the capsule group (P = 0.346). Moreover, the administered tablet form of MMF (500 mg) provides convenience of taking drugs and cost-effectiveness for enrolled kidney transplant recipients.

Conclusion: Low-dose MMF in tablet form combined with tacrolimus can be considered as an efficacious and safe immunosuppressive regimen in the early period after kidney transplantation.

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