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Lupus NephritisPhase 2PLUMMNCT05538208

The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

A Phase 2 study testing Mycophenolate Mofetil in people with Lupus Nephritis, run by Children's Hospital Medical Center, Cincinnati at 19 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 8 to 20 years
Conditions the study is for
Lupus Nephritis
What is being tested?
Mycophenolate Mofetil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
19 sitesUnited States
Study dates
7 Jun 2024to Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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;
  • Subjects may have been previously diagnosed with LN. For study inclusion, the kidney biopsy must be interpreted as one of the following classes: Class 3, Class 3/5, Class 4, or Class 4/5.
  • Treatment of LN with twice daily MMF as per the decision of the treating physician.
  • The subject will have taken MMF as prescribed by their treating physician for a minimum of 4 days (or 8 doses).
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  • Subject tolerates MMF as per the treating physician's opinion;
  • Able to swallow MMF tablets and capsules;
  • If subject is treated with belimumab, must be IV or SQ;
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
  • Evidence of a personally signed and dated Informed Consent document and Assent document (as appropriate) indicating that the subject and a legally acceptable representative/ parent(s)/legal guardian has been informed of all pertinent aspects of the study.
  • Parent or legal guardian must have a smart phone available and able to support the PLUMM smart phone application.
  • Must be able to complete study questionnaires in English or Spanish.

Who cannot join

  • 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;
  • Need for renal replacement therapy within 2 weeks from Baseline Subjects can have required short-term renal replacement therapy prior to Baseline, for example due to preceding acute kidney injury.
  • Infections:
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  • Untreated latent or active tuberculosis (TB);
  • Chronic infections requiring treatment;
  • A subject known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B;
  • Diagnosis of any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within 4 weeks prior to Baseline visit;
  • Any treated infections within 2 weeks of Baseline visit;
  • History of infected joint prosthesis with prosthesis still in situ;
  • Blood dyscrasias, including:
  • Hemoglobin <8.5 g/dL or Hematocrit <22%;
  • White Blood Cell count <2.6 x 109/L;
  • Neutrophil count <1.2 x 109/L;
  • Platelet count <100 x 109/L;
  • Lymphocyte count <0.5 x 109/L.
  • 8) Estimated glomerular filtration rate [GFR] <40 mL/min/1.73 m2 calculated using the CKiD U25 equation (see Appendix 4);
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal;
  • Vaccinated or exposed to a live or attenuated vaccine within the 4 weeks prior to Baseline visit;
  • History or current symptoms suggestive of lymphoproliferative disorders (e.g., Epstein Barr Virus [EBV] related lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma);
  • Current malignancy or history of any malignancy with the exception of adequate treated or excised basal cell or squamous cell or cervical cancer in situ;
  • Recent (within 4 weeks prior to Baseline visit) significant trauma or major surgery;
  • Herbal supplements with pharmaceutical properties must be discontinued at least 1week prior to Baseline visit, unless there are sufficient data available regarding the duration of an herbal medication's pharmacokinetic and pharmacodynamic effects to allow a shorter or longer washout to be specified (e.g., 5 half-lives).
  • Oral or intravenous cyclophosphamide must be discontinued 12 weeks prior to Baseline visit
  • Use of prohibited prescription medication as listed in Appendix 3 within the specified time frame prior to Baseline visit
  • Participation in other studies involving investigational drug(s) within 4 weeks or 5 half-lives (whichever is longer) prior to Baseline visit and/or during study participation; Exposure to investigational biologics should be discussed with the Sponsor.
  • Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use two highly effective methods of contraception or are abstinent for the duration of the study;
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Angela Sr CRC contact

513-803-2118

plumm@cchmc.org

Cat Clinical Research Coordinator contact

513-636-7299

Catherine.Robben@cchmc.org

19 sites in 1 country

United States19 sites, 19 recruiting

  • Akron Children's Hospital

    Akron, Ohio, 44307

    Jessica Clinical Research Nurse, 330-603-2234, JKracker@akronchildrens.org

    Kathryn Cook, DO

    Recruiting

  • Emory Children's Center

    Atlanta, Georgia, 30322

    Heather Clinical Research Coordinator, 404-712-8037, heather.jung@emory.edu

    Larry Greenbaum, MD, MPH

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Ana Clinical Research Coordinator, 303-913-5450, Ana.Aristiguieta@childrenscolorado.org

    Katharine Moore, MD

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Carolina Pastrana-Medina, carol825@med.unc.edu

    Eveline Wu, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Susannnah Program Coordinator, 843-792-8317, wakefies@musc.edu

    Natasha Ruth, M.D., M.S.

    Recruiting

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60614

    Gabby Clinical Research Coordinator, 312-227-6277, GAMorgan@luriechildrens.org

    Pooja Patel, DO

    Recruiting

  • University of Chicago Medicine- Comer Children's

    Chicago, Illinois, 60637

    Melissa Director Pediatric Clinical Trials Office, 773-702-2927, mmarx@bsd.uchicago.edu

    Coughi Edens, MD

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45223

    Cat Clinical Research Coordinator, 513-636-7299, Catherine.Robben@cchmc.org

    Hermine I Brunner, MD

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Katrina Clinical Research Coordinator, 216-286-7453, katrina.gogin@uhhospitals.org

    R. Ezequiel Borgia, M.D M.S

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Cindy Clinical Research Nurse, 614-722-0504, Cindy.Dong@nationwidechildrens.org

    Stacy Ardoin, M.D., M.S.

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Amanda Nowakowski, 551-996-3114, amanda.nowakowski@hmhn.org

    Anna Carmela Gironella, MD

    Recruiting

  • Baylor College of Medicine Pediatric Immunology Allergy Rheumatology

    Houston, Texas, 77030

    Monica Guevara, 832-824-1206, Monica.Guevara@bcm.edu

    Marietta DeGuzman, MD

    Recruiting

  • Children's Wisconsin/Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Nathan Clinical Research Coordinator, 414-266-5662, njsimon@mcw.edu

    Ellen Cody, MD

    Recruiting

  • Hospital for Special Surgery

    New York, New York, 10021

    Julia Klauss, 212-774-2703, klaussj@HSS.EDU

    Karen Onel, MD

    Recruiting

  • Children's Hospital at Montefiore

    New York, New York, 10467

    Emily Clinical Research Coordinator, 718-696-2402, egillies@montefiore.org

    Dawn Wahezi, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Suzy Clinical Research Coordinator, 801-585-5067, suzy.richins@hsc.utah.edu

    Aimee Hersh, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94518

    Zilan Clinical Research Coordinator, (415) 353-1301, zilan.zheng@ucsf.edu

    Emily von Scheven, M.D., M.A.S.

    Recruiting

  • Seattle Children's Hospital/University of Washington

    Seattle, Washington, 98105

    Megan Clinical Research Supervisor, 206-200-3502, megan.kelton@seattlechildrens.org

    Kristen Hayward, MD, MS

    Recruiting

  • Washington University in St. Louis School of Medicine

    St Louis, Missouri, 63110

    Joseph Clinical Research Coordinator, 314-747-1349, dumayas@wustl.com

    Brian Stotter, MD

    Recruiting

Other trials in United States

About this study

Official title: Efficacy & Safety of Pharmacokinetically-Driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis- A Double-Blind Placebo Controlled Clinical 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.

Read the detailed description

Subjects will be randomized 1:1 to receive blinded treatment with MMFPK or MMFBSA for up to 53 weeks. The primary endpoint, clinical remission of LN, is measured at the end of Part 1 at week 26. Subjects in the MMFBSA arm who have only partial renal response (PRR) at the end of Part 1 will newly receive MMFPK upon entering Part 2 of the study (week 26 - 53). Subjects with complete renal responses (CRR) at the end of Part 1 will continue the same dosing regimen of MMF (MMFBSA or MMFPK) in Part 2 as was given in Part 1 of the study. Subjects in the MMFPK arm with PRR at the end of Part 1 will enter Part 2 and continue in the MMFPK arm.

Subjects who are LN non-responders by the end of Part 1 at week 26 will be considered treatment failures and discontinued from the study intervention. All subjects who are discontinued from the study intervention for reasons of efficacy or safety will receive LN treatment and monitoring as per the treating physician's decision. However, these subjects will be asked to participate in study visits at weeks 26 and 53/End of Study.

Conditions
Lupus Nephritis
Medical subject headings
Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mycophenolate MofetilDrug

    Also called MMF dosed per body surface area

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

  • Mycophenolate MofetilDrug

    Also called MMF dosed phrmacokinetically

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

Study groups in NCT05538208
Study groupRoleWhat they receive
MMFBSAActive comparatorMMF dosed as per body-surface area
Receives: Drug: Mycophenolate Mofetil
MMFPKExperimentalMMF dosed as per pharmacokinetically-guided precision-dosing
Receives: Drug: Mycophenolate Mofetil

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 26 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2022
  2. Study start7 Jun 2024
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible patients enrolled in the study will be randomized (1:1) at baseline to the 53-week double-blind, active comparator 2-part study to receive either MMFPK or MMFBSA. Subjects who are partial renal responders (PRR) to MMFBSA at week 26, will cross over to the MMFPK arm. Complete renal responders (CRR) at week 26 in MMFBSA arm will continue to be treated with MMFBSA. Subjects with at least a PRR (or even CRR) in the MMFPK arm at week 26 will remain in the MMFPK arm and continue to receive MMF dosage targeting MPA-AUC0-12 \> 60-70 mg\*h/l. Subjects whose LN fails to respond to therapy by week 26 will be discontinued from the study interventions to receive LN treatment as per their local physician's decision. Subjects who experience a single episode of a LN flare during Part 1 of the study or fulfill other criteria for discontinuation from the study intervention, will also receive LN treatment as per their local physician's decision.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05538208
Sponsor's protocol ID
ML42264
Other IDs
1R01AR079124-01A1
Acronym
PLUMM
Status last verified
Sep 2026
First submitted
9 Sep 2022
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Sponsor fulfills its commitment to publicly disclose clinical trial results through posting the results of studies on ClinicalTrials.gov, or EudraCT, and/or www.cincinnatichildrens.com, and other public registries in accordance with applicable local laws/regulations. In all cases, study results are reported by the Sponsor regardless of the outcome of the study. Every effort will be made to report the basic results within 1 year of the end of the trial. Results will be posted at www.clinicaltrials.gov/. For all publications relating to the study, the institution and investigators will comply with recognized ethical standards concerning publications and authorship, including Section II - "Ethical Considerations in the Conduct and Reporting of Research" of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, http://www.icmje.org/index.html#authorship. A Publication Committee will be established to oversee publication of the results.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mycophenolate Mofetil in people with Lupus Nephritis, run by Children's Hospital Medical Center, Cincinnati at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Angela Sr CRC (513-803-2118, plumm@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the efficacy of MMFPK therapy to the efficacy of MMFBSA therapy (time frame: 26 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05538208.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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