The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
PLUMM
Efficacy & Safety of Pharmacokinetically-Driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis- A Double-Blind Placebo Controlled Clinical Trial
2 other identifiers
interventional
105
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2024
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedStudy Start
First participant enrolled
June 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
March 18, 2026
March 1, 2026
2.1 years
September 9, 2022
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the efficacy of MMFPK therapy to the efficacy of MMFBSA therapy
the percentage of subjects achieving at least partial remission of LN (PRR) as per the adapted ACR/EULAR Criteria at Week 26
26 week
Study Arms (2)
MMFBSA
ACTIVE COMPARATORMMF dosed as per body-surface area
MMFPK
EXPERIMENTALMMF dosed as per pharmacokinetically-guided precision-dosing
Interventions
MMF dosed 600mg/m2 body surface area per dose about every 12 hours
Eligibility Criteria
You may qualify if:
- Male or female aged 8 to \< 21 years;
- Must meet Classification Criteria for SLE as per the criteria of the American College of Rheumatology (ACR)/ European League Against Rheumatism
- Diagnosed with proliferative LN as per the International Society of Nephrology/Renal Pathology Society4 based on kidney biopsy done within 90 days prior to enrollment into the study;
- Treatment of LN with twice daily MMF as per the decision of the treating physician.
- The subject will have taken MMF as prescribed by their treating physician for a minimum of 4 days (or 8 doses).
- Subject tolerates MMF as per the treating physician's opinion;
- Able to swallow MMF tablets and capsules;
- If subject is treated with belimumab, must be IV or SQ;
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
- Evidence of a personally signed and dated Informed Consent document and Assent document (as appropriate) indicating that the subject and a legally acceptable representative/ parent(s)/legal guardian has been informed of all pertinent aspects of the study.
- Parent or legal guardian must have a smart phone available and able to support the PLUMM smart phone application.
- Must be able to complete study questionnaires in English or Spanish.
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;
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of California, San Francisco
San Francisco, California, 94518, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Emory Children's Center
Atlanta, Georgia, 30322, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614, United States
University of Chicago Medicine- Comer Children's
Chicago, Illinois, 60637, United States
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Children's Hospital at Montefiore
New York, New York, 10467, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Akron Children's Hospital
Akron, Ohio, 44307, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45223, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor College of Medicine Pediatric Immunology Allergy Rheumatology
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Seattle Children's Hospital/University of Washington
Seattle, Washington, 98105, United States
Children's Wisconsin/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hermine I Brunner, MD
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- During this double-blinded study, the Sponsor, subject, and investigator site staff will all be blinded to the subject's treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division Director Rheumatology
Study Record Dates
First Submitted
September 9, 2022
First Posted
September 13, 2022
Study Start
June 7, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- within one year for
- Access Criteria
- results are available to the public
The Sponsor fulfills its commitment to publicly disclose clinical trial results through posting the results of studies on ClinicalTrials.gov, or EudraCT, and/or www.cincinnatichildrens.com, and other public registries in accordance with applicable local laws/regulations. In all cases, study results are reported by the Sponsor regardless of the outcome of the study. Every effort will be made to report the basic results within 1 year of the end of the trial. Results will be posted at www.clinicaltrials.gov/. For all publications relating to the study, the institution and investigators will comply with recognized ethical standards concerning publications and authorship, including Section II - "Ethical Considerations in the Conduct and Reporting of Research" of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, http://www.icmje.org/index.html#authorship. A Publication Committee will be established to oversee publication of the results.