The Pediatric Lupus Nephritis Mycophenolate Mofetil
PLUMM
What is the goal of the study?
The safety and effectiveness of mycophenolate mofetil (MMF) for the treatment of lupus nephritis (LN) has been tested in adult and some pediatric subjects. MMF, a prodrug is rapidly converted to the active moiety mycophenolic acid (MPA) which has been found to be of significant benefit to patients after renal transplant and with LN. The Sponsor is proposing to conduct a 2-year 3-part double-blinded placebo controlled 2-arm clinical trial. The study goal is to determine the safety and efficacy of MMFPK compared to MMFBSA for the treatment of proliferative LN in subjects 8 to <18 years. treatment arms are (1) mmf dosed as per body-surface area (mmfbsa; 600mg m2 body surface area per dose about every 12 hours) and (2) pharmacokinetically-guided precision-dosing of mmf (mmfpk; mmf dosed twice daily to achieve an area under the concentration-time curve (auc0-12h) of mpa>60-70 mg*h/L).
Who can participate in the study?
Please contact the study team listed below to learn more.