Efficacy and Safety of Pharmacokinetically-Driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis-A Double-Blind Placebo Controlled Clinical Trial (The Pediatric Lupus Nephritis Mycophenolate Mofetil Study).
Year: 2024
Type: article
Abstract: Background: The safety and efficacy of mycophenolate mofetil (MMF) for lupus nephritis (LN) treatment is established in adults and in some children. MMF is rapidly converted to the biologically active metabolite mycophenolic acid (MPA) whose pharmacokinetics (PK) is characterized by large inter- and intra-individual variability. Methods/Design: treatment until week 53. Subjects who achieve PRR at week 26 are discontinued from study intervention. Discussion: for both safety and efficacy. This study has the potential to change current treatment recommendations for pediatric LN, thereby significantly impacting childhood-onset SLE (cSLE) disease prognosis and current clinical practice.
Source: PubMed
Authors: Anna Carmela P Sagcal-Gironella, Angela Merritt, Tomoyuki Mizuno, Vikas R Dharnidharka, Joseph McDonald, Marietta DeGuzman, Dawn Wahezi, Beatrice Goilav, Karen Onel, Susan Kim, Ellen Cody, Eveline Y Wu, Laura Cannon, Kristen Hayward, Daryl M Okamura, Pooja N Patel, Larry A Greenbaum, Kelly A Rouster-Stevens, Jennifer C Cooper, Natasha M Ruth, Stacy Ardoin, Kathryn Cook, R Ezequiel Borgia, Aimee Hersh, Bin Huang, Prasad Devarajan, Hermine Brunner
Institutions: Hackensack University Medical Center, Hackensack Meridian School of Medicine, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Washington University in St. Louis, University of Chicago, Baylor College of Medicine, Albert Einstein College of Medicine, Children's Hospital at Montefiore, Hospital for Special Surgery, Weill Cornell Medicine, University of California, San Francisco, Medical College of Wisconsin, University of North Carolina at Chapel Hill, University of Washington, Northwestern University, Lurie Children's Hospital, Emory University, Children's Healthcare of Atlanta, University of Colorado Denver, Medical University of South Carolina, Nationwide Children's Hospital, Abigail Wexner Research Institute, Akron Children's Hospital, Rainbow Babies & Children's Hospital, University of Utah
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4400898900