Recruiting

Proteinuria Testing

Sponsor:

NYU Langone Health

Code:

NCT07823478

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home Urine Testing

Study Details

Brief 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.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT07823478

Start date

Sep 8, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Weekly Home-Based Proteinuria Testing

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.

no intervention: Standard of Care

Participants randomized to the standard of care arm will receive standard of care.

Interventions

Home 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.

Primary outcome measure

  • Number of Participants who Become Biopsy-Eligible [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Peter Izmirly, MD

212-263-5802Peter.Izmirly@nyulangone.org

Jill Buyon, MD

212-263-0743Jill.Buyon@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-09-16.