Phase 4
Completed N=20
A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients
Source: ClinicalTrials.gov NCT02444143 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Difference in Tacrolimus Exposure (AUC-0-24)) in Obese Patients Who Received an Initial TAC -ER Dose of 0.15 mg/kg Using aBW Versus IBW — 115.2; 90.0; 268.3; 269.3 ng•h/mL — p=0.29
◆ Published Evidence
Established
47citations · ~9 / year
Interventions for weight loss in people with chronic kidney disease who are overweight or obese.
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).
Linked Publications (2)
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Interventions for weight loss in people with chronic kidney disease who are overweight or obese.
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A randomized, open-label pharmacokinetic trial of tacrolimus extended-release dosing in obese de novo kidney transplant recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Tacrolimus Exposure (AUC-0-24)) in Obese Patients Who Received an Initial TAC -ER Dose of 0.15 mg/kg Using aBW Versus IBW |
115.2; 90.0; 268.3; 269.3; 355.0; 267.3 | 0.29 |
| SECONDARY Difference in Time to Therapeutic Level |
4.9; 5.1 | 0.90 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02444143) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.