The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
Status:
Not yet recruiting
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
Summary
The study is a 1-year 2-part double-blinded placebo controlled 2-arm clinical trial.
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. 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.
Phase:
Phase 2
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborators:
Genentech, Inc. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)