NCT05538208Toboroz2. fázis

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 14.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter): Toboroz
Fázis (regiszter): 2. fázis
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 105 (tervezett)
Első benyújtás: 2022. szept. 9.
Kezdés: 2024. jún. 7.
Elsődleges befejezés: 2027. jan.
Fő szponzor: Children's Hospital Medical Center, Cincinnati
Betegségek: Lupus (SLE)
NCT-szám: NCT05538208

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó · 2. fázis
Tervezett résztvevők: 105
2024. jún. 7. és az elsődleges befejezés (2027. jan.) között
19 helyszín, 1 országban
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Korábbi kezelés

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:
- 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;
Vaccinated or exposed to a live or attenuated vaccine within the 4 weeks prior to Baseline visit;
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.

Más betegség

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 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;

Laborértékek

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;
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.

Egyéb

Perceived or stated inability to adhere to the study protocol;
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;

A regiszterben nem jelölt feltételek

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;
- 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).
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.

Életkor a regiszterben: 8 év – 20 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (19)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
Akron Children's Hospital	Akron	Egyesült Államok	Toboroz
Emory Children's Center	Atlanta	Egyesült Államok	Toboroz
Children's Hospital Colorado	Aurora	Egyesült Államok	Toboroz
University of North Carolina at Chapel Hill	Chapel Hill	Egyesült Államok	Toboroz
Medical University of South Carolina	Charleston	Egyesült Államok	Toboroz
University of Chicago Medicine- Comer Children's	Chicago	Egyesült Államok	Toboroz
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Egyesült Államok	Toboroz
Cincinnati Children's Hospital Medical Center	Cincinnati	Egyesült Államok	Toboroz
University Hospitals Cleveland Medical Center*	Cleveland	Egyesült Államok	Toboroz
Nationwide Children's Hospital	Columbus	Egyesült Államok	Toboroz
Hackensack University Medical Center	Hackensack	Egyesült Államok	Toboroz
Baylor College of Medicine Pediatric Immunology Allergy Rheumatology	Houston	Egyesült Államok	Toboroz
Children's Wisconsin & Medical College of Wisconsin	Milwaukee	Egyesült Államok	Toboroz
Children's Hospital at Montefiore	New York	Egyesült Államok	Toboroz
Hospital for Special Surgery	New York	Egyesült Államok	Toboroz
University of Utah	Salt Lake City	Egyesült Államok	Toboroz
University of California San Francisco	San Francisco	Egyesült Államok	Toboroz
Seattle Children's Hospital; University of Washington	Seattle	Egyesült Államok	Toboroz
Washington University in St. Louis, School of Medicine	St Louis	Egyesült Államok	Toboroz

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