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The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
NCT05538208 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Mycophenolate Mofetil
Study Locations (19)
Ohio
- Akron Children's Hospital — Akron
- Cincinnati Children's Hospital Medical Center — Cincinnati
- University Hospitals Cleveland Medical Center — Cleveland
- Nationwide Children's Hospital — Columbus
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
- University of Chicago Medicine- Comer Children's — Chicago
New York
- Hospital for Special Surgery — New York
- Children's Hospital at Montefiore — New York
California
- University of California, San Francisco — San Francisco
Colorado
- Children's Hospital Colorado — Aurora
Georgia
- Emory Children's Center — Atlanta
Missouri
- Washington University in St. Louis School of Medicine — St Louis
New Jersey
- Hackensack University Medical Center — Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2024-06-07 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05538208
The ClinicalTrials.gov registry entry for NCT05538208 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 715 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 1 intervention — of which Mycophenolate Mofetil is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05538208 reports 19 study locations spanning 14 distinct geographic areas — top geographies include Ohio, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05538208 about?
NCT05538208 is a clinical study titled "The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study". 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 t...
What is the current status of trial NCT05538208?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2024-06-07. Estimated completion is 2027-01.
What conditions does trial NCT05538208 study?
This clinical trial studies the following conditions: Lupus Nephritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05538208?
The interventions under investigation include: Mycophenolate Mofetil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05538208?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 715 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05538208 being conducted?
This trial has 19 study locations across California, Colorado, Georgia, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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