EFFICACY & SAFETY OF PHARMACOKINETICALLY-DRIVEN DOSING OF MYCOPHENOLATE MOFETIL FOR THE TREATMENT OF PEDIATRIC PROLIFERATIVE LUPUS NEPHRITIS - A DOUBLE-BLIND PLACEBO CONTROLLED CLINICAL TRIAL

Primary Objective

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.

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Details
Age

Child

Eligibility

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 daysNew 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

Locations

Childrens Hospital Colorado

Principal Investigator
Photograph of Jennifer Cooper

Jennifer Cooper

Study ID

Protocol Number: 22-2004

More information available at ClinicalTrials.gov: NCT05538208

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