An interventional study of Home Urine Testing in Systemic Lupus Erythematosus, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Diagnostic
Among 13 studies in Lupus Erythematosus, Systemic by NYU Langone Health — 4 open to participants now, 5 under way, 1 of them phase 3. Lupus Erythematosus, Systemic · NYU Langone Health.
Among the 13 studies in Lupus Erythematosus, Systemic by NYU Langone Health, this one is the 5th largest by planned enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 with no phase, and was the 13th registered.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →4 of the 13 studies in Lupus Erythematosus, Systemic by NYU Langone Health are open now, in 1 country. Recruiting first, the newest first:
NYU Langone Health · Sites in United States
Ages 18+
NYU Langone Health · Sites in United States
Ages 55+
NYU Langone Health · Sites in United States
Ages 18–90
By country, each count listing its studies:
Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 92 (32%) set no upper age limit and 162 (57%) stop at 75 or younger; 54 take children under 18; 34 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 160 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Median enrollment 154 across the 11 interventional studies, 138 across the 2 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.
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NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Lupus Erythematosus, Systemic by NYU Langone Health, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 randomized to the standard of care arm will receive standard of care.
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.
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.
Time frame: Month 12
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
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.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2028, 24 months after the start.
Of 122 non-industry interventional studies with no phase under Lupus Erythematosus, Systemic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 24 months is close to that.
Counting every sponsor, half of 129 studies reached it within 23 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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