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

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Georgia
Emory Children's Center
RECRUITING
Atlanta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
University of Chicago Medicine- Comer Children's
RECRUITING
Chicago
Missouri
Washington University in St. Louis School of Medicine
RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
Children's Hospital at Montefiore
RECRUITING
New York
Hospital for Special Surgery
RECRUITING
New York
Ohio
Akron Children's Hospital
RECRUITING
Akron
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Nationwide Children's Hospital
RECRUITING
Columbus
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Baylor College of Medicine Pediatric Immunology Allergy Rheumatology
RECRUITING
Houston
Utah
University of Utah
RECRUITING
Salt Lake City
Washington
Seattle Children's Hospital/University of Washington
RECRUITING
Seattle
Wisconsin
Children's Wisconsin/Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Angela Sr CRC
plumm@cchmc.org
513-803-2118
Backup
Cat Clinical Research Coordinator
Catherine.Robben@cchmc.org
513-636-7299
Time Frame
Start Date: 2024-06-07
Estimated Completion Date: 2027-01
Participants
Target number of participants: 105
Treatments
Active_comparator: MMFBSA
MMF dosed as per body-surface area
Experimental: MMFPK
MMF dosed as per pharmacokinetically-guided precision-dosing
Sponsors
Collaborators: Genentech, Inc., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov

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