Actively Recruiting
The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-18
105
Participants Needed
19
Research Sites
134 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 8 to under 21 years
- Meets Classification Criteria for Systemic Lupus Erythematosus (SLE) by ACR/EULAR
- Diagnosed with proliferative lupus nephritis (Class 3, 3/5, 4, or 4/5) confirmed by kidney biopsy within 90 days prior to enrollment
- Receiving twice daily mycophenolate mofetil treatment as determined by treating physician, with at least 4 days (8 doses) taken
- Tolerates mycophenolate mofetil according to treating physician
- Able to swallow MMF tablets or capsules
- If treated with belimumab, must be intravenous or subcutaneous
- Willing and able to comply with scheduled visits, treatments, lab tests, and study procedures
- Has signed informed consent and assent documents as appropriate
- Parent or guardian has a smartphone capable of supporting the PLUMM study app
- Able to complete study questionnaires in English or Spanish
You will not qualify if you...
- Unable or unwilling to adhere to study protocol
- Allergy or hypersensitivity to mycophenolate mofetil or its components
- Presence of severe, progressive, or uncontrolled chronic diseases affecting liver, blood, gastrointestinal, metabolic, endocrine, lung, heart, or nervous system
- History of kidney disease other than lupus nephritis
- Requires renal replacement therapy within 2 weeks before baseline visit
- Untreated latent or active tuberculosis, chronic infections, HIV, Hepatitis B, or recent serious infections requiring hospitalization or antibiotics
- History of infected joint prosthesis still in place
- Blood disorders including low hemoglobin, hematocrit, white blood cells, neutrophils, platelets, or lymphocytes below specified thresholds
- Estimated glomerular filtration rate below 40 mL/min/1.73 m2
- Elevated liver enzymes (AST or ALT) over 1.5 times upper normal limit
- Vaccinated with live or attenuated vaccine within 4 weeks before baseline
- History or symptoms of lymphoproliferative disorders or current malignancy except certain treated skin or cervical cancers
- Recent major trauma or surgery within 4 weeks before baseline
- Use of herbal supplements with drug effects within 1 week before baseline unless otherwise justified
- Use of oral or intravenous cyclophosphamide within 12 weeks before baseline
- Use of prohibited medications or participation in other investigational drug studies within specified timeframes
- Pregnant or breastfeeding females; males with pregnant partners; or unwilling/unable to use effective contraception
- Other severe medical or psychiatric conditions increasing risk or interfering with study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
University of California, San Francisco
San Francisco, California, United States, 94518
Actively Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Emory Children's Center
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60614
Actively Recruiting
5
University of Chicago Medicine- Comer Children's
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Washington University in St. Louis School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
8
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
9
Children's Hospital at Montefiore
New York, New York, United States, 10467
Actively Recruiting
10
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
11
Akron Children's Hospital
Akron, Ohio, United States, 44307
Actively Recruiting
12
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45223
Actively Recruiting
13
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
14
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
15
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
16
Baylor College of Medicine Pediatric Immunology Allergy Rheumatology
Houston, Texas, United States, 77030
Actively Recruiting
17
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
18
Seattle Children's Hospital/University of Washington
Seattle, Washington, United States, 98105
Actively Recruiting
19
Children's Wisconsin/Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
A
Angela Sr CRC
CONTACT
C
Cat Clinical Research Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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