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

Completed · Phase 4

Conditions studied: Kidney Transplantation

In brief

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).

Key facts

Study ID

NCT02444143

Run by

University of Illinois at Chicago

People needed

20

Starts

2015-05-01

Expected to finish

2017-06-09

Last updated by the study team

2018-11-07

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is a recipient of a living donor or deceased donor kidney only transplant
• Subject is > 18 years of age
• BMI≥30 on POD 0

You may not qualify if…

• Multi-organ transplant
• Subjects taking tacrolimus pre-transplant (i.e. positive crossmatch transplants or re-transplants)
• Patients undergoing simultaneous sleeve gastrectomy at the time of transplant.

Where it is running

• University of Illinois Hospital & Health Sciences System — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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