A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients

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).

Timeline

Start

2015-05

Primary completion

2017-02-28

Completion

2017-06-09

Outcome

Missed primary endpoint

paper Results of the primary outcome (AUC0-24) on Study Day 1, 7, and 14 were not statistically different between the two groups. PMID 31206808 ↗

registry analysis (other test); Ideal Body Weight- Tacrolimus Extended Release vs Adjusted Body Weight-Tacrolimus Extended Release; p = 0.29; t-test, 2 sided NCT02444143 ↗

Publications

• Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.
• Jasiak-Panek NM, Wenzler E, Patel S, Thielke JJ, Progar K, Patel S, Brandt S, Huang YJ, Benedetti E, West-Thielke PM. A randomized, open-label pharmacokinetic trial of tacrolimus extended-release dosing in obese de novo kidney transplant recipients. Clin Transplant. 2019 Aug;33(8):e13640. doi: 10.1111/ctr.13640. Epub 2019 Jul 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tacrolimus	Small molecule	0.15 mg/kg	—

Indications

No indication recorded.