Efficacy and Safety of Pharmacokinetically-Driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis-A Double-Blind Placebo Controlled Clinical Trial (The Pediatric Lupus Nephritis Mycophenolate Mofetil Study).

ABSTRACT:

Background

The safety and efficacy of mycophenolate mofetil (MMF) for lupus nephritis (LN) treatment is established in adults and in some children. MMF is rapidly converted to the biologically active metabolite mycophenolic acid (MPA) whose pharmacokinetics (PK) is characterized by large inter- and intra-individual variability.

Methods/design

This randomized, double-blind, active comparator, controlled clinical trial of pediatric subjects with proliferative LN compares pharmacokinetically-guided precision-dosing of MMF (MMF_PK, i.e. the dose is adjusted to the target area under the concentration-time curve (AUC_0-12h) of MPA ≥ 60-70 mg*h/L) and MMF dosed per body surface area (MMF_BSA, i.e. MMF dosed 600 mg/m² body surface area), with

SUBMITTER: Sagcal-Gironella ACP 

PROVIDER: S-EPMC11258879 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature