The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

Recruiting now · Phase 2

Conditions studied: Lupus Nephritis

In brief

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.

Key facts

Study ID

NCT05538208

Run by

Children's Hospital Medical Center, Cincinnati

People needed

105

Starts

2024-06-07

Expected to finish

2027-01-01

Last updated by the study team

2026-03-18

Who can join

Age: 8 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Perceived or stated inability to adhere to the study protocol;
• Hypersensitivity to MMF or any component of the drug product;
• Presence of features (from SLE or other chronic disease) that a-priori suggest that the subject benefits from other therapies than that suggested or allowable by the study protocol; These disease features include but are not limited to severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
• History of other kidney disease besides LN or prior to the diagnosis of SLE;
• Need for renal replacement therapy within 2 weeks from Baseline Subjects can have required short-term renal replacement therapy prior to Baseline, for example due to preceding acute kidney injury.
• Infections:
• Untreated latent or active tuberculosis (TB);
• Chronic infections requiring treatment;
• A subject known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B;
• Diagnosis of any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within 4 weeks prior to Baseline visit;
• Any treated infections within 2 weeks of Baseline visit;
• History of infected joint prosthesis with prosthesis still in situ;
• Blood dyscrasias, including:
• Hemoglobin <8.5 g/dL or Hematocrit <22%;
• White Blood Cell count <2.6 x 109/L;
• Neutrophil count <1.2 x 109/L;
• Platelet count <100 x 109/L;
• Lymphocyte count <0.5 x 109/L.
• 8) Estimated glomerular filtration rate [GFR] <40 mL/min/1.73 m2 calculated using the CKiD U25 equation (see Appendix 4);
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal;
• Vaccinated or exposed to a live or attenuated vaccine within the 4 weeks prior to Baseline visit;
• History or current symptoms suggestive of lymphoproliferative disorders (e.g., Epstein Barr Virus [EBV] related lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma);
• Current malignancy or history of any malignancy with the exception of adequate treated or excised basal cell or squamous cell or cervical cancer in situ;
• Recent (within 4 weeks prior to Baseline visit) significant trauma or major surgery;
• Herbal supplements with pharmaceutical properties must be discontinued at least 1week prior to Baseline visit, unless there are sufficient data available regarding the duration of an herbal medication's pharmacokinetic and pharmacodynamic effects to allow a shorter or longer washout to be specified (e.g., 5 half-lives).

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Emory Children's Center — Atlanta, Georgia, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• University of Chicago Medicine- Comer Children's — Chicago, Illinois, United States (enrolling)
• Washington University in St. Louis School of Medicine — St Louis, Missouri, United States (enrolling)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Hospital for Special Surgery — New York, New York, United States (enrolling)
• Children's Hospital at Montefiore — New York, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Akron Children's Hospital — Akron, Ohio, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Baylor College of Medicine Pediatric Immunology Allergy Rheumatology — Houston, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Seattle Children's Hospital/University of Washington — Seattle, Washington, United States (enrolling)
• Children's Wisconsin/Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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