Effect of Serum Parathyroid Hormone on Tacrolimus Therapy in Kidney Transplant Patients: A Possible Biomarker for a Tacrolimus Dosage Schedule

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  • Hirata Kenshiro
    Department of Pharmacy, Japanese Red Cross Kumamoto Hospital
  • Watanabe Hiroshi
    Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University Center for Clinical Pharmaceutical Sciences, School of Pharmacy, Kumamoto University
  • Toyoda Mariko
    Department of General Internal Medicine, Japanese Red Cross Kumamoto Hospital
  • Sugimoto Ryusei
    Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University
  • Ikegami Komei
    Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University
  • Imafuku Tadashi
    Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University
  • Matsuzaka Kotaro
    Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University
  • Ichimizu Shota
    Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University
  • Maeda Hitoshi
    Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University Center for Clinical Pharmaceutical Sciences, School of Pharmacy, Kumamoto University
  • Uekihara Sohichi
    Department of General Internal Medicine, Japanese Red Cross Kumamoto Hospital
  • Jingami Sachiko
    Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University
  • Maruyama Toru
    Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University Center for Clinical Pharmaceutical Sciences, School of Pharmacy, Kumamoto University

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<p>The mechanism responsible for the decreased extra-renal CYP3A activity in chronic kidney disease (CKD) patients remains unknown. Using an animal model, we previously found that elevated levels of serum intact parathyroid hormone (iPTH) caused a reduced CYP3A activity. This retrospective observational study assessed the relationship between serum iPTH levels and the blood concentration or dosage of tacrolimus, a CYP3A substrate, after oral administration in kidney transplant patients. Thirty-four patients were enrolled who had kidney transplants between April 2014 and March 2016 and who had been administrated once- daily prolonged-release tacrolimus (Graceptor®, Astellas Pharm Inc.). Among the 34 patients, 22 had taken a CYP3A inhibitor. These patients were excluded from the study. A significant positive correlation between serum iPTH and tacrolimus trough levels was found at 4 d before kidney transplantation in 12 patients who were not receiving potent CYP3A inhibitor. In addition, serum iPTH levels before transplantation could serve as a factor for the dose of tacrolimus up to 1 year after transplantation. Monitoring serum iPTH levels could predict the trough level for the initial administration of tacrolimus, and may serve as an index for the initial dose of tacrolimus in kidney transplantation patients.</p>

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