RecruitingPhase 2

The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
8 Years to 20 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 53 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Subjects will be randomized 1:1 to receive blinded treatment with MMFPK or MMFBSA for up to 53 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 1-year study compares two ways to set the dose of mycophenolate mofetil (MMF): using body size or using drug levels in the blood. It tests how safe and effective these methods are for people ages 8 to 20 with lupus nephritis, a type of kidney swelling and damage caused by lupus.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 8 to 20 and meet the study’s rules for a lupus diagnosis.
  • Have a kidney tissue test within 90 days before joining that shows lupus nephritis class 3, 3/5, 4, or 4/5.
  • Have taken doctor-prescribed MMF twice a day for at least 4 days (8 doses), and be able to tolerate it.
  • Be able to swallow MMF tablets and capsules.
  • If taking belimumab, receive it through a vein or as a shot under the skin.
  • Be willing and able to follow the study plan, including visits, tests, and treatments, and provide the required signed consent forms.
  • Have a parent or legal guardian with a smartphone that can run the PLUMM study app.
  • Be able to complete study surveys in English or Spanish.

Who can't join

  • Cannot follow the study plan, have an allergy to MMF or its ingredients, or have a serious health condition that needs other treatment or makes the study unsafe.
  • Have kidney disease other than lupus nephritis, kidney disease before lupus, kidney filtering below the study’s limit, or need treatment to replace kidney function within 2 weeks of the starting visit.
  • Have certain infections, including untreated tuberculosis, HIV, hepatitis B, or a long-term infection needing treatment. Recent treated or serious infections and an infected artificial joint still in place also may rule you out.
  • Have blood cell counts below the study’s limits or liver blood test results more than 1.5 times the upper normal limit.
  • Have certain blood or immune-cell growth disorders, or current or past cancer, except certain fully treated skin cancers or very early cervical cancer.
  • Had a live or weakened-virus vaccine, major surgery, or a serious injury in the 4 weeks before the starting visit.
  • Use medicines or herbal products that are not allowed, or have not stopped them long enough before the study. Recent or ongoing studies of experimental drugs also may rule you out.
  • Are pregnant or breastfeeding, or are male with a pregnant partner. People who can have children must meet the study’s rules for two highly effective birth control methods or not having sex during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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. 4. 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). 5. Subject tolerates MMF as per the treating physician's opinion; 6. Able to swallow MMF tablets and capsules; 7. If subject is treated with belimumab, must be IV or SQ; 8. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; 9. 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. 10. Parent or legal guardian must have a smart phone available and able to support the PLUMM smart phone application. 11. Must be able to complete study questionnaires in English or Spanish. Exclusion Criteria: 1. Perceived or stated inability to adhere to the study protocol; 2. Hypersensitivity to MMF or any component of the drug product; 3. 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. 4. History of other kidney disease besides LN or prior to the diagnosis of SLE; 5. 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. 6. Infections: 1. Untreated latent or active tuberculosis (TB); 2. Chronic infections requiring treatment; 3. A subject known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B; 4. Diagnosis of any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within 4 weeks prior to Baseline visit; 5. Any treated infections within 2 weeks of Baseline visit; 6. History of infected joint prosthesis with prosthesis still in situ; 7. Blood dyscrasias, including: 1. Hemoglobin \<8.5 g/dL or Hematocrit \<22%; 2. White Blood Cell count \<2.6 x 109/L; 3. Neutrophil count \<1.2 x 109/L; 4. Platelet count \<100 x 109/L; 5. Lymphocyte count \<0.5 x 109/L. 8. 8\) Estimated glomerular filtration rate \[GFR\] \<40 mL/min/1.73 m2 calculated using the CKiD U25 equation (see Appendix 4); 9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the upper limit of normal; 10. Vaccinated or exposed to a live or attenuated vaccine within the 4 weeks prior to Baseline visit; 11. History or current symptoms suggestive of lymphoproliferative disorders (e.g., Epstein Barr Virus \[EBV\] related lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma); 12. 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; 13. Recent (within 4 weeks prior to Baseline visit) significant trauma or major surgery; 14. 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). 15. Oral or intravenous cyclophosphamide must be discontinued 12 weeks prior to Baseline visit 16. Use of prohibited prescription medication as listed in Appendix 3 within the specified time frame prior to Baseline visit 17. 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. 18. 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; 19. 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.

Study sites (19)

CA

CO

GA

IL

MO

NC

  • University of North Carolina at Chapel Hill · Chapel Hill, NC 27599Carolina Pastrana-Medina · Study contact · carol825@med.unc.eduEveline Wu, MD · Principal investigatorLaura Cannon, MD · Principal investigatorMore trials in Chapel Hill

NJ

NY

OH

SC

TX

UT

WA

WI