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The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

NCT05538208 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-03-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Mycophenolate Mofetil

MMF dosed 600mg/m2 body surface area per dose about every 12 hours

DRUG

Mycophenolate Mofetil

MMF dosed twice daily to achieve an area under the concentration-time curve (AUC 0-12h) of MPA \>=60-70 mg\*h/L

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Hermine I Brunner, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-07
Primary Completion
2026-07-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05538208 on ClinicalTrials.gov