Evidence map›Paper›PMID 39035447›Full record

ArticleJournal of clinical trials2024

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).

Anna Carmela P Sagcal-Gironella, Angela Merritt, Tomoyuki Mizuno, Vikas R Dharnidharka, Joseph McDonald, Marietta DeGuzman, Dawn Wahezi, Beatrice Goilav, Karen Onel, Susan Kim and 17 more

Abstract read
PubMed Full text at PMC
In one paragraph

Article in Journal of clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Anna Carmela P Sagcal-GironellaDivision of Pediatric Rheumatology, Hackensack University Medical Center, Hackensack, New Jersey, USA.
Angela MerrittDivision of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Tomoyuki MizunoDivision of Translational and Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Vikas R DharnidharkaDepartment of Pediatric Nephrology, Washington University School of Medicine, Saint Louis, Missouri, USA.
Joseph McDonaldDepartment of Pediatrics, University of Chicago, Chicago, Illinois, USA.
Marietta DeGuzmanDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas, USA.
Dawn WaheziDepartment of Pediatric Rheumatology, Children's Hospital at Montefiore, Albert Einstein College of Medicine, Bronx, New York, USA.
Beatrice GoilavPediatric Nephrology, The Children's Hospital at Montefiore, Albert Einstein College of Medicine, Bronx, New York, USA.
Karen OnelDepartment of Pediatric Rheumatology, Hospital for Special Surgery, Weill Cornell Medicine, New York, New York, USA.
Susan KimDepartment of Rheumatology, University of California, San Francisco, California, USA.
Ellen CodyDepartment of Pediatric Nephrology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Eveline Y WuDepartment of Pediatric Rheumatology, University of North Carolina, Chapel Hill, North Carolina, USA.
Laura CannonDepartment of Pediatric Rheumatology, University of North Carolina, Chapel Hill, North Carolina, USA.
Kristen HaywardDepartment of Pediatric Rheumatology, University of Washington, Seattle, Washington, USA.
Daryl M OkamuraDepartment of Pediatric Nephrology, University of Washington, Seattle, Washington, USA.
Pooja N PatelDepatrment of Pediatric Rheumatology, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University, Chicago, Illinois, USA.
Larry A GreenbaumDepartment of Pediatric Nephrology, Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
Kelly A Rouster-StevensDepartment of Pediatrics, Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
Jennifer C CooperDepartment of Pediatric Rheumatology, University of Colorado, Denver, Colorado, USA.
Natasha M RuthDepartment of Pediatric Rheumatology, Medical University of South Carolina, Charleston, South Carolina, USA.
Stacy ArdoinAbigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, Ohio, USA.
Kathryn CookDivision of Rheumatology, Akron Children's, Akron, Ohio, USA.
R Ezequiel BorgiaDepartment of Pediatric Allergy, Immunology and Rheumatology, UH Rainbow Babies & Children's Hospital, Cleveland, Ohio, USA.
Aimee HershDepartment of Pediatrics, Immunology and Rheumatology, University of Utah, Salt Lake City, Utah, USA.
Bin HuangDepartment of Pediatrics, University of Cincinnati College of Medicine and Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Prasad DevarajanDepartment of Nephrology and Hypertension, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Hermine BrunnerDivision of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.

Funding

LCenter for Clinical and Translational Science and TrainingUL1TR001425 · NCATS · UNIVERSITY OF CINCINNATI · PI MEINZEN-DERR, JAREEN, STRAWN, JEFFREY ROBERT · 2015 to 2024
$37.5M
Tissue Repository CoreP30AR070549 · NIAMS · CINCINNATI CHILDRENS HOSP MED CTR · PI Grant Sanford Schulert · 2016 to 2026
$7.7M
The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) StudyR01AR079124 · NIAMS · CINCINNATI CHILDRENS HOSP MED CTR · PI Hermine I Brunner, PRASAD DEVARAJAN · 2022 to 2026
$5.3M
Pediatric musculOskeletal & RheumaTology Innovation COre center (PORTICO)P30AR076316 · NIAMS · CINCINNATI CHILDRENS HOSP MED CTR · PI BRUNNER, HERMINE I · 2019 to 2023
$3.4M
Improving Pediatric Lupus Nephritis Through Personalized Mycophenolate Mofetil TherapyR34AR071651 · NIAMS · CINCINNATI CHILDRENS HOSP MED CTR · PI BRUNNER, HERMINE I, VINKS, ALEXANDER A · 2018 to 2019
$420k
NCATS NIH HHS UL1 TR001425NIAMS NIH HHS P30 AR070549NIAMS NIH HHS P30 AR076316NIAMS NIH HHS R01 AR079124NIAMS NIH HHS R34 AR071651
6 · The paper itself

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: This randomized, double-blind, active comparator, controlled clinical trial of pediatric subjects with proliferative LN compares pharmacokinetically-guided precision-dosing of MMF (MMF Discussion: The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) study will provide a thorough evaluation of the PK of MMF in pediatric LN patients, yielding a head-to-head comparison of MMF

Indexed as

Childhood-onsetLupusLupus nephritisMycophenolate mofetilPediatricPharmacokineticsSLE

Identifiers

PMID39035447
PMCPMC11258879

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.