The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
Sponsor: Children's Hospital Medical Center, Cincinnati • ClinicalTrials.gov ID: NCT05538208
Recruiting for Similar Conditions?
Sponsors are looking for patients like you. See if you qualify for compensated research studies.
Check Eligibility →Description
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.
Interventions
-
Mycophenolate Mofetil
(Drug)
MMF dosed 600mg/m2 body surface area per dose about every 12 hours
-
Mycophenolate Mofetil
(Drug)
MMF dosed twice daily to achieve an area under the concentration-time curve (AUC 0-12h) of MPA \>=60-70 mg\*h/L
Eligibility criteria
Conditions
Locations
- University of California, San Francisco — San Francisco, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Emory Children's Center — Atlanta, Georgia, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- University of Chicago Medicine- Comer Children's — Chicago, Illinois, United States
- Washington University in St. Louis School of Medicine — St Louis, Missouri, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Hospital for Special Surgery — New York, New York, United States
- Children's Hospital at Montefiore — New York, New York, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Akron Children's Hospital — Akron, Ohio, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Baylor College of Medicine Pediatric Immunology Allergy Rheumatology — Houston, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
- Seattle Children's Hospital/University of Washington — Seattle, Washington, United States
- Children's Wisconsin/Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Partner with Nurenyx
Showcase your study to thousands of motivated patients matching your criteria.
Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record