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

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.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Procedure: Home Urine Testing

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Izmirly, MD; Phone Number: 212-263-5802; Email: Peter.Izmirly@nyulangone.org
• Study Contact Backup: Name: Jill Buyon, MD; Phone Number: 212-263-0743; Email: Jill.Buyon@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: 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.
No Intervention: Standard of Care; Participants randomized to the standard of care arm will receive standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Peter Izmirly, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: September 11, 2026
• First Submitted That Met QC Criteria: September 11, 2026
• First Posted (Actual): September 16, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 23-00682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Peter.Izmirly@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Requests should be directed to Peter.Izmirly@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No