Mycophenolate Mofetil for Lupus Nephritis

The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

Recruiting Phase 2 Interventional Study
Lupus Nephritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
8 – 20
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
105 (estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati · Other
Who this trial is looking for

This trial is looking for young people aged 8 to 20 with lupus nephritis. Participants will take a medication called Mycophenolate Mofetil and visit the study site regularly for assessments.

Are You a Good Fit for This Trial?
Must be taking Mycophenolate Mofetil
Rules you out TuberculosisHIVHepatitis B

You may be able to join if

  • I am between 8 and 20 years old.
  • I have been diagnosed with lupus nephritis.
  • I have taken Mycophenolate Mofetil for at least 4 days.
  • I can swallow tablets or capsules.
  • I have signed the consent forms required.
  • I can complete questionnaires in English or Spanish.

You may not be able to join if

  • I cannot follow the study rules.
  • I am allergic to Mycophenolate Mofetil.
  • I have other severe health issues.
  • I have a history of other kidney diseases.
  • I am currently pregnant or breastfeeding.
  • I have certain infections that need treatment.
  • I had major surgery or trauma in the last 4 weeks.
  • I have had a recent severe medical condition.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
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 go…
Trial Locations
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Eligibility Criteria
Inclusion 1. Male or female aged 8 to \< 21 years; 2. Must meet Classification Criteria for SLE as per the criteria of the American College of Rheumatology (ACR)/ European League Against Rheumatism 3. Diagnosed with proliferative LN as per the International Society of Nephrology/Renal Pathology Soc…
Contacts

Angela Sr CRC

513-803-2118

plumm@cchmc.org

CONTACT

Cat Clinical Research Coordinator

513-636-7299

Catherine.Robben@cchmc.org

CONTACT