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
To compare the efficacy of MMFPK therapy to the efficacy of MMFBSA therapy as measured by the percentage of subjects achieving at least partial remission of LN (PRR) as per the adapted ACR/EULAR Criteria at Week 26 (end of Part 1) of the study.
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
Jennifer Cooper
Study ID
Protocol Number: 22-2004
More information available at ClinicalTrials.gov: NCT05538208
Is this Study for You?
Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers