drugset / Trial / NCT05538208
The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
Phase 2
Recruiting
105 enrolled
Children's Hospital Medical Center, Cincinnati
Genentech, Inc. · collabNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-06-07
- Primary completion
- 2026-07
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 600 mg/m2 | — |