A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients
Status:
Completed
Trial end date:
2017-06-09
Target enrollment:
Participant gender:
Summary
Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day
dosing regimen. This formulation has the potential to improve compliance. Current dosing
recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day
administered once daily in the morning. There are no specifications on appropriate dosing in
obese patients or on whether to use actual, ideal or and adjusted weight. It will be
advantageous to understand the pharmacokinetics of this medication in the obese to determine
the appropriate dosing regimen. In this study, obese patients will be randomized to receive
tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or
adjusted body weight (aBW).