The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
ConditionLupus Nephritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-20
SponsorChildren's Hospital Medical Center, Cincinnati
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 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Mycophenolate Mofetil
- Mycophenolate Mofetil
Treatment groups
105 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Genentech, Inc.
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov