Solid Organ Transplantation: The Kidney
Demographic Considerations in Tacrolimus Pharmacokinetics

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Kidney Pretransplantation. Ten patients with end-stage renal disease who were awaiting kidney transplantation received an intravenous dose of 0.02 mg/kg of tacrolimus administered continuously over 4 hours. After a 7 day wash-out, patients also received a single oral dose of tacrolimus at 0.08 mg/kg. Oral doses were taken in a fasted state. Whole blood concentrations of tacrolimus were measured over 72 hours post-dose.

Kidney Posttransplantation. Twenty-eight adult patients who were within 7

Race

The demographic profile of normal volunteers and patients who were studied for bioavailability and pharmacokinetic assessments are shown in Table 1. There were no significant differences in the demographic profile of blacks versus non-blacks. A total of 13 blacks were evaluated and compared to 41 non-blacks. There was a trend towards lower body weight in the black population which was not statistically significant.

The mean pharmacokinetic parameters of these populations are shown in Table 2.

Discussion

Previous investigations into the pharmacokinetics of tacrolimus have shown that the major determinants of the pharmacokinetic profile are the patient population studied and the severity of hepatic dysfunction. Renal transplant patients have shown higher clearance rates of tacrolimus compared to liver transplant patients or normal volunteers. In a population pharmacokinetic assessment of adult liver transplant patients, no effects of gender on pharmacokinetics of tacrolimus were seen; however,

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