Observational studyClinical pharmacokinetics2026
Population Pharmacokinetic Modelling of Unbound Mycophenolic Acid and its Glucuronide in Adult Kidney Transplant Recipients in Early Post-Transplant.
Observational study in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
8 authors.
Funding
Abstract
BACKGROUND AND
objectiveThe first-line immunosuppressant mycophenolic acid (MPA) is characterised by complex, variable pharmacokinetics (PK) with high protein binding, where the relationship between total and unbound drug can be difficult to predict early post-transplant. We developed a novel population pharmacokinetic (popPK) model for unbound MPA and its major glucuronide (MPAG) in adult kidney transplant recipients to characterise the pharmacologically relevant unbound drug.
methodsThis prospective, observational study included de novo adult kidney transplant recipients on steady-state oral mycophenolate mofetil with tacrolimus (±prednisone). The PopPK modelling was performed using stochastic approximation expectation-maximisation, and simulations evaluated the impact of significant covariates on unbound MPA area-under the concentration-time curves (AUC)
resultsForty-one participants (aged 48.3±12.1 years, mean±SD) from 63 occasions representing three study visits (~1, ~3, and ~6 months post-transplant) were enrolled. A structural model based on first-order absorption (k
conclusionsA popPK model simultaneously characterising unbound MPA and MPAG was developed and evaluated. Simulations indicated that age-dependent MPA dosing may be warranted to optimise unbound therapeutic exposures.
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