Home urine testing for people with lupus
Official title: 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
Run by NYU Langone Health · NCT07823478 · Data updated 2026-11-12
Participants with lupus will try weekly home urine tests in addition to usual care to see if this helps monitor kidney health over a year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | September 8, 2026 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2028 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT07823478 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ with lupus who consent to participate and meet defined diagnostic criteria and kidney history status.
✕Probably not a fit
Patients without lupus nephritis risk or who do not engage with weekly texting may not benefit from home testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, 1:1 study enrolls adults with systemic lupus erythematosus who agreed to be contacted for research and have documented kidney risk. Participants are assigned to either weekly home-based proteinuria testing plus standard care or standard care alone for 12 months. Those in the home-testing arm report their results via weekly text messages to the study team. The sponsor is NYU Langone Health with collaboration from the CDC, and the study location is NYU Langone Health in New York. The aim is to determine whether home testing can support closer monitoring and timely interventions for lupus-related kidney involvement.
Why it matters
Potential benefit: If successful, patients may experience earlier detection of kidney involvement and potentially better kidney health through more timely care.
How similar studies have gone: Prior work in home-based monitoring shows promise in improving disease management for chronic conditions, but this approach in lupus nephritis is developing and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
NYU Langone Health
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Peter Izmirly, MD — NYU Langone Health
- Study coordinator: Peter Izmirly, MD
- Email: Peter.Izmirly@nyulangone.org
- Phone: 212-263-5802
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.