The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
- Conditions
- Lupus Nephritis
- Registration Number
- NCT05538208
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 105
Inclusion<br><br> 1. Male or female aged 8 to < 18 years;<br><br> 2. Must meet Classification Criteria for SLE as per the criteria of the American<br> College of Rheumatology (ACR)/ European League Against Rheumatism 1-3 (Appendix 0);<br><br> 3. Newly diagnosed with proliferative LN as per the International Society of<br> Nephrology/Renal Pathology Society4 based on kidney biopsy done within 60 days prior<br> to enrollment into the study;<br><br> Subjects may have been previously diagnosed with other Classes of LN. For study<br> inclusion, the kidney biopsy must be newly interpreted as one of the following<br> classes: Class 3, Class 3/5, Class 4, or Class 4/5.<br><br> 4. SLEDAI renal domain score > 0;<br><br> 5. Treatment of LN with twice daily MMF as per the decision of the treating physician.<br><br> The subject will have taken MMF as prescribed by their treating physician for a<br> minimum of 4 days (or 8 doses).<br><br> 6. Subject tolerates MMF as per the treating physician's opinion;<br><br> 7. Able to swallow MMF tablets and capsules;<br><br> 8. If subject is treated with belimumab, must be IV or SQ;<br><br> 9. Subjects who are willing and able to comply with scheduled visits, treatment plan,<br> laboratory tests, and other study procedures;<br><br> 10. Evidence of a personally signed and dated Informed Consent document and Assent<br> document (as appropriate) indicating that the subject and a legally acceptable<br> representative/ parent(s)/legal guardian has been informed of all pertinent aspects<br> of the study.<br><br> 11. Parent or legal guardian must have a smart phone available and able to support the<br> PLUMM smart phone application.<br><br> 12. Must be able to complete study questionnaires in English or Spanish.<br><br>Exclusion Criteria:<br><br> 1. Perceived or stated inability to adhere to the study protocol;<br><br> 2. Hypersensitivity to MMF or any component of the drug product;<br><br> 3. Presence of features (from SLE or other chronic disease) that a-priori suggest that<br> the subject benefits from other therapies than that suggested or allowable by the<br> study protocol; These disease features include but are not limited to severe,<br> progressive, or uncontrolled hepatic, hematologic, gastrointestinal, metabolic,<br> endocrine, pulmonary, cardiac or neurologic disease.<br><br> 4. History of other kidney disease besides LN or prior to the diagnosis of SLE;<br><br> 5. Need for renal replacement therapy within 2 weeks from Baseline Subjects can have<br> required short-term renal replacement therapy prior to Baseline, for example due to<br> preceding acute kidney injury.<br><br> 6. Infections:<br><br> 1. Untreated latent or active tuberculosis (TB);<br><br> 2. Chronic infections requiring treatment;<br><br> 3. A subject known to be infected with Human Immunodeficiency Virus (HIV),<br> Hepatitis B;<br><br> 4. Any infection requiring hospitalization, parenteral antimicrobial therapy or<br> judged to be opportunistic by the investigator within 4 weeks prior of Baseline<br> visit;<br><br> 5. Any treated infections within 2 weeks of Baseline visit;<br><br> 6. History of infected joint prosthesis with prosthesis still in situ;<br><br> 7. Blood dyscrasias, including:<br><br> 1. Hemoglobin <8.5 g/dL or Hematocrit <22%;<br><br> 2. White Blood Cell count <2.6 x 109/L;<br><br> 3. Neutrophil count <1.2 x 109/L;<br><br> 4. Platelet count <100 x 109/L;<br><br> 5. Lymphocyte count <0.5 x 109/L.<br><br> 8. Estimated glomerular filtration rate [GFR] <40 mL/min/1.73 m2 calculated using the<br> modified Schwartz equation5 (see Appendix 4);<br><br> 9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the<br> upper limit of normal;<br><br> 10. Vaccinated or exposed to a live or attenuated vaccine within the 4 weeks prior to<br> Baseline visit;<br><br> 11. History or current symptoms suggestive of lymphoproliferative disorders (e.g.,<br> Epstein Barr Virus [EBV] related lymphoproliferative disorder, lymphoma, leukemia,<br> myeloproliferative disorders, or multiple myeloma);<br><br> 12. Current malignancy or history of any malignancy with the exception of adequate<br> treated or excised basal cell or squamous cell or cervical cancer in situ;<br><br> 13. Recent (within 4 weeks prior to Baseline visit) significant trauma or major surgery;<br><br> 14. Herbal supplements with pharmaceutical properties must be discontinued at least<br> 1week prior to Baseline visit, unless there are sufficient data available regarding<br> the duration of an herbal medication's pharmacokinetic and pharmacodynamic effects<br> to allow a shorter or longer washout to be specified (e.g., 5 half-lives).<br><br> 15. Hydroxychloroquine exceeding 5mg/kg/day or started within 1 week prior to Baseline<br> visit;<br><br> 16. Oral or intravenous cyclophosphamide must be discontinued 12 weeks prior to Baseline<br> visit<br><br> 17. Rituximab or other selective B lymphocyte depleting agents: Must be discontinued for<br> 6 months prior to Baseline visit or CD19/20+ counts must be normal by FACS analysis;<br><br> 18. Use of prohibited prescription medication as listed in Appendix 3 within the<br> specified time frame prior to Baseline visit<br><br> 19. Participation in other studies involving investigational drug(s) within 4 weeks or 5<br> half-lives (whichever is longer) prior to Baseline visit and/or during study<br> participation; Exposure to investigational biologics should be discussed with the<br> Sponsor.<br><br> 20. Pregnant female subjects; breastfeeding female subjects; male subjects with partners<br> currently pregnant; male subjects able to father children and female subjects of<br> childbearing potential who are unwilling or unable to use two highly effective<br> methods of contraception or are abstinent (see Section 4.4.) for the duration of the<br> study;<br><br> 21. Other severe acute or chronic medical or psychiatric condition or laboratory<br> abnormality that may increase the risk associated with study participation or<br> investigational product administration or may interfere with the interpretation of<br> study results and, in the judgment of the investigator, would make the subject<br> inappropriate for entry into this study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of MMFPK therapy to the efficacy of MMFBSA therapy
- Secondary Outcome Measures
Name Time Method