HEALTH Home Urinalysis Testing

NCT07823478 | Recruiting DMC

• 1 other identifier: 23-00682
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants who Become Biopsy-Eligible

  Becoming "biopsy-eligible" is defined as standard of care, clinically-indicated kidney biopsy for either de novo kidney disease or a relapse in a patient with preexisting kidney disease previously in remission.

  Month 12

Study Arms (2)

Weekly Home-Based Proteinuria Testing

EXPERIMENTAL

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.

Procedure: Home Urine Testing

Standard of Care

NO INTERVENTION

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

Interventions

Home Urine Testing PROCEDURE

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.

Weekly Home-Based Proteinuria Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter Izmirly, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Izmirly, MD

CONTACT

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

Jill Buyon, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start: September 8, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: Requests should be directed to Peter.Izmirly@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)