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Lupus Nexus Landmark Study: A Prospective Registry and Biorepository
The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).
This is a multicenter registry and biorepository conducted in the United States (US) and Canada. The registry will enroll over 3500 individuals with SLE over the course of five years into one of following four cohorts: * New Onset: individuals with a new diagnosis of SLE * Active Lupus Nephritis: individuals with a recent diagnosis of LN * Extra-Renal Lupus Flare: individuals who have experienced a recent flare * Prevalent Cases: individuals with lupus who do not meet the criteria for one of the other cohorts The registry data will include but is not limited to: patient demographics, medical history, clinician-reported outcomes (ClinROs), patient-reported outcomes (PROs), social history and determinants of health, and environmental exposures. Participants will also be asked to allow access to their medical records. Biological samples, including whole blood, urine, saliva, stool and tissue will be collected throughout the study. These biospecimens will be used for a broad range of analyses, including genetics, genomics, proteomics, biomarker discovery and microbiome profiling.
Age
18 - 110 years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Wallace Rheumatic Studies Center
Beverly Hills, California, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Massachusetts Memorial Health
Worcester, Massachusetts, United States
Washington University
St Louis, Missouri, United States
The Feinstein Institutes for Medical Research
Manhasset, New York, United States
Columbia University Medical Center
New York, New York, United States
Start Date
June 28, 2023
Primary Completion Date
December 1, 2035
Completion Date
December 1, 2035
Last Updated
August 15, 2025
3,500
ESTIMATED participants
Lead Sponsor
Lupus Research Alliance
NCT06647069
NCT05126277
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07015983