The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
NCT05538208
This study is recruiting at 19 US sites in 14 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Lupus Nephritis
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Last updated on ClinicalTrials.gov
- September 14, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- University of California, San Francisco · San Francisco, CA
Colorado · 1
- Children's Hospital Colorado · Aurora, CO
Georgia · 1
- Emory Children's Center · Atlanta, GA
Illinois · 2
- Ann & Robert H. Lurie Children's Hospital of Chicago · Chicago, IL
- University of Chicago Medicine- Comer Children's · Chicago, IL
Missouri · 1
- Washington University in St. Louis School of Medicine · St Louis, MO
New Jersey · 1
- Hackensack University Medical Center · Hackensack, NJ
New York · 2
- Children's Hospital at Montefiore · New York, NY
- Hospital for Special Surgery · New York, NY
North Carolina · 1
- University of North Carolina at Chapel Hill · Chapel Hill, NC
Ohio · 4
- Akron Children's Hospital · Akron, OH
- Cincinnati Children's Hospital Medical Center · Cincinnati, OH
- University Hospitals Cleveland Medical Center · Cleveland, OH
- Nationwide Children's Hospital · Columbus, OH
South Carolina · 1
- Medical University of South Carolina · Charleston, SC
Texas · 1
- Baylor College of Medicine Pediatric Immunology Allergy Rheumatology · Houston, TX
Utah · 1
- University of Utah · Salt Lake City, UT
Washington · 1
- Seattle Children's Hospital/University of Washington · Seattle, WA
Wisconsin · 1
- Children's Wisconsin/Medical College of Wisconsin · Milwaukee, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.