EFFICACY & SAFETY OF PHARMACOKINETICALLY-DRIVEN DOSING OF MYCOPHENOLATE MOFETIL FOR THE TREATMENT OF PEDIATRIC PROLIFERATIVE LUPUS NEPHRITIS - A DOUBLE-BLIND PLACEBO CONTROLLED CLINICAL TRIAL
Compare the efficacy of two MMF therapies as measured by the percentage of subjects achieving at least partial remission of LN (PPR) as per the adapted ACR/EULAR Criteria at Week 26 of the study. To compare the efficacy of both MMF therapies as measured by the percentage of patients achieving complete remission of LN (CRR) as per the adapted ACR/EULAR Criteria at Week 26.
Child
Age 8 to <18 years Meet Classification Criteria for SLE per criteria from ACR/EULAR New diagnoses with proliferative Lupus Nephritis based on Kidney Biopsy within 60 days
New LN interpretations Must be Class 3, 3/5, 4, or 4/5 SLEDAI renal Domain Score > 0 Able to tolerate MMF and swallow tablets/capsules Parent or guardian with smart phone and able to support PLUMM smart phone application English or Spanish Speaking
Treatment
National
Childrens Hospital Colorado
Jennifer Cooper, MD
Protocol Number: 22-2004
More information available at ClinicalTrials.gov: NCT05538208
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