Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Mycophenolate Mofetil

    Drug

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

  • Mycophenolate Mofetil

    Drug

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

Treatment groups

105 Participants
are divided into 2 treatment groups
Group A: MMFBSAActive comparator 1 intervention
Group B: MMFPKExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To compare the efficacy of MMFPK therapy to the efficacy of MMFBSA therapy

the percentage of subjects achieving at least partial remission of LN (PRR) as per the adapted ACR/EULAR Criteria at Week 26

Time frame
26 week

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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