RecruitingNot ApplicableNCT07823478

HEALTH Home Urinalysis Testing

An Evaluation Of Home Urinalysis Testing For Systemic Lupus Erythematosus (SLE) Patients At Elevated Risk For Developing Lupus Nephritis: A Pilot Stage And Randomized, Controlled Study

Sponsor

NYU Langone Health

Enrollment

160 participants

Start Date

Sep 8, 2026

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria3

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)

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Interventions

PROCEDUREHome Urine Testing

Participants will perform weekly home urine testing with a dipstick. Participants will be collecting urine, evaluate it for protein level, and report results to study team via text message. Once results have been reported, urine collected at home will be destroyed.