Efficacy & Safety of Pharmacokinetically-Driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis- A Double-Blind Placebo Controlled Clinical Trial
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.
• Male or female aged 8 to \< 21 years;
• Must meet Classification Criteria for SLE as per the criteria of the American College of Rheumatology (ACR)/ European League Against Rheumatism
• Diagnosed with proliferative LN as per the International Society of Nephrology/Renal Pathology Society4 based on kidney biopsy done within 90 days prior to enrollment into the study;
• Subjects may have been previously diagnosed with LN. For study inclusion, the kidney biopsy must be interpreted as one of the following classes: Class 3, Class 3/5, Class 4, or Class 4/5.
• Treatment of LN with twice daily MMF as per the decision of the treating physician.
• The subject will have taken MMF as prescribed by their treating physician for a minimum of 4 days (or 8 doses).
• Subject tolerates MMF as per the treating physician's opinion;
• Able to swallow MMF tablets and capsules;
• If subject is treated with belimumab, must be IV or SQ;
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
• Evidence of a personally signed and dated Informed Consent document and Assent document (as appropriate) indicating that the subject and a legally acceptable representative/ parent(s)/legal guardian has been informed of all pertinent aspects of the study.
⁃ Parent or legal guardian must have a smart phone available and able to support the PLUMM smart phone application.
⁃ Must be able to complete study questionnaires in English or Spanish.