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

• Status: Completed
• Trial end date: 2017-06-09
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

1. The subject is a recipient of a living donor or deceased donor kidney only transplant

2. Subject is > 18 years of age

3. BMI≥30 on POD 0

Exclusion Criteria:

1. Multi-organ transplant

2. Subjects taking tacrolimus pre-transplant (i.e. positive crossmatch transplants or re-transplants)

3. Patients undergoing simultaneous sleeve gastrectomy at the time of transplant.