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NCT07823478NARecruiting

HEALTH Home Urinalysis Testing

NYU Langone Health

Start Date

9/8/2026

Completion Date

9/30/2028

Summary

Study participants enrolled in the SAMPLE Biorepository (s14-00487) who have provided permission to be contacted for future research will be enrolled and randomized (1:1) two-arm controlled) to either 1) perform weekly home-based proteinuria testing in addition to standard of care or 2) standard of care only. Participants randomized to the home-based proteinuria testing arm will perform weekly home-based proteinuria testing in addition to having standard of care and respond to study team's weekly text messages with urine test results for one year.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 18 years or older * Willing to provide informed consent * Lupus diagnosis: Four of the ACR criteria,19,20 four of the SLICC criteria,21 and/or the recent ACR/EULAR criteria, which requires an ANA of 1:80 or greater plus a score of 10 points. * If the patient had previous kidney disease (documented UCPR \>0.5 as part of ACR, SLICC or EULAR criteria and preferably a biopsy such that Class can be recorded), the patient is now in clinical remission as defined by a UPCR \<0.3 at the current visit regardless of any serologic activity. Relapse rates of lupus nephritis occurs in approximately one-third of patients. * If no history of previous kidney disease, diagnosis of SLE within 5 years of the current visit, a positive anti-dsDNA and or low C3 or C4 levels, and current UPCR \<0.3. These parameters were chosen since the development of lupus nephritis is generally within the first years of SLE diagnosis,1-3 and often patients have serologic activity antedating clinical proteinuria.210 * Ownership of any mobile phone. * Must be enrolled in SAMPLE Biorepository (s14-00487) Exclusion Criteria: * Unwillingness or inability of the patient to participate, or in the opinion of the investigator the patient does not understand the consent form or speaks a language other than English, Spanish, or Mandarin * If the patient does not own a mobile phone * Patient not enrolled in SAMPLE Biorepository (s14-00487)

Interventions

PROCEDURE

Home Urine Testing

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Conditions

Systemic Lupus Erythematosus

Locations

NYU Langone Health

New York, New York 10016

United States