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New treatment option for Lupus Nephritis
Official title The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
ClinicalTrials.gov ID: NCT05538208
What this study is testing
What is Mycophenolate Mofetil?
Mycophenolate Mofetil is an investigational medicine, given as an once-daily, being studied as a potential treatment for lupus nephritis.
Also referred to as MMF dosed per body surface area.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 53 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 20
You may be able to join if
- Inclusion
- 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...
- 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...
You likely can't join if
- 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...
- History of other kidney disease besides LN or prior to the diagnosis of SLE;
- Need for renal replacement therapy within 2 weeks from Baseline people can have required short-term renal replacement therapy prior to Baseline, for...
- Infections:
See the full eligibility criteria
- Inclusion
- 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; people may have been previously...
- 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).
- 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;
- people 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...
- 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.
- 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...
- History of other kidney disease besides LN or prior to the diagnosis of SLE;
- Need for renal replacement therapy within 2 weeks from Baseline people can have required short-term renal replacement therapy prior to Baseline, for example due to preceding acute kidney injury.
- Infections:
- 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...
- 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...
- Pregnant female people; breastfeeding female people; male people with partners currently pregnant; male people able to father children and female people of childbearing potential who are unwilling or unable to use two...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Akron, Ohio, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Charleston, South Carolina, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 53 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 20 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; St Louis, Missouri, United States; Hackensack, New Jersey, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.