The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

Recruiting Phase 2 Interventional Study
Lupus Nephritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
8 – 20
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
105 (estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati · Other
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About This Trial
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 go…
Trial Locations
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Eligibility Criteria
Inclusion 1. Male or female aged 8 to \< 21 years; 2. Must meet Classification Criteria for SLE as per the criteria of the American College of Rheumatology (ACR)/ European League Against Rheumatism 3. Diagnosed with proliferative LN as per the International Society of Nephrology/Renal Pathology Soc…
Contacts

Angela Sr CRC

513-803-2118

plumm@cchmc.org

CONTACT

Cat Clinical Research Coordinator

513-636-7299

Catherine.Robben@cchmc.org

CONTACT