New Lupus Nephritis MMF Study
What is the purpose of this study?
Pediatric Lupus Nephritis Mycophenolate Mofetil Study (PLUMM) is a 1-year double-blind active comparator trial to compare the efficacy & safety of Mycophenolate Mofetil (MMF) dosed based on patient body-surface area (MMFBSA) to pharmacokinetically-driven precision-dosing of MMF (MMFPK) in children & adolescents with proliferative LN.
The objective is to show superior efficacy and acceptable safety of MMF precision dosing compared to current standard of care for the treatment of children newly diagnosed with proliferative lupus nephritis. Patients will be randomized to either standard of care body-surface area dosing (MMFBSA) or pharmacokinetically-driven precision-dosing of MMF (MMFPK.)
The primary endpoint is partial renal at week 26 with the key secondary endpoint being complete renal remission at 26.
Who will be included in this study?
Enrollment will consist of:
Patients diagnosed with proliferative LN confirmed by kidney biopsy done within 90 days of enrollment
Diagnosed with childhood-onset SLE as per the ACR criteria
Age 8 – 20 years at the time of enrollment
·Prescribed and tolerating MMF as per the treating physician
What is involved?
All participants will come for a screening visit and 8 study visits. Study visits will be similar to regular clinic visits with additional urine collections, optional research blood draws alongside standard of care labs, questionnaires, and PK samples taken using finger sticks and volumetric micro sampling (VAMS) devices.
What is the pay?
Participants will be compensated $X at each visit for their participation.