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
Conditions
Systemic Lupus Erythematosus
Locations
NYU Langone Health
New York, New York 10016
United States