The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study (NCT05538208) | Clinical Trial Compass
RecruitingPhase 2
The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
United States105 participantsStarted 2024-06-07
Plain-language 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.
Who can participate
Age range8 Years – 20 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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;
Exclusion criteria
✕. 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.
What they're measuring
1
To compare the efficacy of MMFPK therapy to the efficacy of MMFBSA therapy
Timeframe: 26 week
Trial details
NCT IDNCT05538208
SponsorChildren's Hospital Medical Center, Cincinnati
✕. 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);