The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study (NCT05538208)
Efficacy & Safety of Pharmacokinetically-Driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis- A Double-Blind Placebo Controlled Clinical Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California, San Francisco — San Francisco, California
Age range: 8 Years to 20 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (19 Sites)
- University of California, San Francisco — San Francisco, California
- Children's Hospital Colorado — Aurora, Colorado
- Emory Children's Center — Atlanta, Georgia
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- University of Chicago Medicine- Comer Children's — Chicago, Illinois
- Washington University in St. Louis School of Medicine — St Louis, Missouri
- Hackensack University Medical Center — Hackensack, New Jersey
- Hospital for Special Surgery — New York, New York
- Children's Hospital at Montefiore — New York, New York
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
- Akron Children's Hospital — Akron, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Medical University of South Carolina — Charleston, South Carolina
- Baylor College of Medicine Pediatric Immunology Allergy Rheumatology — Houston, Texas
- University of Utah — Salt Lake City, Utah
- Seattle Children's Hospital/University of Washington — Seattle, Washington
- Children's Wisconsin/Medical College of Wisconsin — Milwaukee, Wisconsin
📞 Contact the Study Coordinator
Phone: (513) 803-2118
Email: plumm@cchmc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Lupus Nephritis
- KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis — Palo Alto, California
- Daratumumab to Treat Active Lupus Nephritis — Rochester, Minnesota
- A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis — Birmingham, Alabama
- Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis — Glendale, Arizona
- An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases — Phoenix, Arizona
- Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis — Birmingham, Alabama
Explore by condition: All Lupus Nephritis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.