No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
160 (estimated)
Sponsor
NYU Langone Health · Other
Who this trial is looking for
This trial is looking for adults with lupus who want to help improve home testing for kidney health. Participants will do weekly urine tests at home and report the results through text messages for one year.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I am willing to provide informed consent.
I have a lupus diagnosis.
I have a mobile phone.
I am enrolled in SAMPLE Biorepository.
You may not be able to join if
I do not understand the consent form or speak English, Spanish, or Mandarin.
I do not own a mobile phone.
I am not enrolled in SAMPLE Biorepository.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 hom…
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.
Trial Locations
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Status
Eligibility 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 ki…
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)
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