Pre-transplant pharmacokinetic profiling and tacrolimus requirements post-transplant.
Author(s): Campbell S, Hawley C, Irish A, Hutchison B, Walker R, Butcher BE, Ferrari P
Affiliation(s): Department of Renal Medicine, Princess Alexandra Hospital, Brisbane, Queensland, Australia. scottb_campbell@health.qld.gov.au
Publication date & source: 2010-10, Nephrology (Carlton)., 15(7):714-9.
Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
AIM: To determine the proportion of patients achieving tacrolimus whole-blood concentrations of >/=10 ng/mL within 3 days of kidney transplantation, after randomization either to standard dosing (control group) or post-transplantation dosing guided by a 2-hour (C(2) ) level following a preoperative tacrolimus dose (T2 group). METHODS: The first postoperative tacrolimus dose was given either according to standard care (control group) or 0.15 mg/kg b.d. if the pre-transplant C(2) level was </=20 ng/mL, 0.1 mg/kg b.d. if the C(2) level was 21-59 ng/mL or 0.05 mg/kg b.d. if the C(2) level was >/=60 ng/mL (T2 group). Subsequent dosing in both groups was based upon tacrolimus trough level monitoring. Participants received concomitant mycophenolate mofetil and steroids. RESULTS: Ninety patients were recruited, of which 84 were included in the analysis (control group n=43; T2 group n=41). There was no difference in the proportion of subjects achieving tacrolimus trough levels >/=10 ng/mL (82.9% Control vs 93.0% T2; P=0.19) or between 10 and 15 ng/mL (41.5% Control vs 41.9% T2; P=0.97) at day 3 post transplant. The T2 group achieved tacrolimus trough levels of >/=10 ng/mL significantly faster than the control group (100% achievement in 14 days (Control) versus 4 days (T2); P=0.01). CONCLUSION: Performing a pre-transplant tacrolimus C(2) does not significantly increase the high proportion of subjects achieving 10 ng/mL tacrolimus concentrations by day 3 using routine protocols. However, compared with standard care, performing a pre-transplant tacrolimus C(2) does lead to patients achieving a whole-blood concentration of >/=10 ng/mL sooner. (c) 2010 The Authors. Nephrology (c) 2010 Asian Pacific Society of Nephrology.
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