Clinical Trial

The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

Study acronym: PLUMM
Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated March 18, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
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 \<21 years.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-09-09; most recent amendment 2026-03-16.
Status change: Not Yet Recruiting → Recruiting 2024-01-10
Trial Details
NCT Number NCT05538208
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: Genentech, Inc., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions Lupus Nephritis
Enrollment 105 participants
Start Date 2024-06-07
Primary Completion 2026-07 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-18