Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA
Research Article
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
Author(s): Anna Carmela P Sagcal-Gironella, Angela Merritt, Tomoyuki Mizuno, Vikas R Dharnidharka, Joseph McDonald, Marietta DeGuzman, Dawn Wahezi, Beatrice Goilav, Karen Onel, Susan Kim, Ellen Cody, Eveline Y Wu, Laura Cannon, Kristen Hayward, Daryl M Okamura, Pooja N Patel, Larry A Greenbaum, Kelly A Rouster-Stevens, Jennifer C Cooper, Natasha M Ruth, Stacy Ardoin, Kathryn Cook, R Ezequiel Borgia, Aimee Hersh, Bin Huang, Prasad Devarajan and Hermine Brunner*
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 (MMFPK, i.e. the dose is adjusted to the target area under the concentration-time curve (AUC0-12h) of MPA ≥ 60-70 mg*h/L) and MMF dosed per body surface area (MMFBSA, i.e. MMF dosed 600 mg/m2 body surface area), with MMF dosage taken about 12
hours apart. At baseline, subj.. View More»
DOI:
10.35248/2167-0870.24.14.563