The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
Efficacy & Safety of Pharmacokinetically-Driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis- A Double-Blind Placebo Controlled Clinical Trial
Children's Hospital Medical Center, Cincinnati
105 participants
Jun 7, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
MMF dosed 600mg/m2 body surface area per dose about every 12 hours
MMF dosed twice daily to achieve an area under the concentration-time curve (AUC 0-12h) of MPA \>=60-70 mg\*h/L
Locations(19)
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NCT05538208