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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests weekly home urine checks for protein along with usual care, compared with usual care alone. It is for adults with lupus who are in the SAMPLE Biorepository and have agreed to be contacted about future research. People are assigned by chance to a group; those doing home tests will text their results to the study team each week for one year.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 or older.
  • Be willing to give informed consent, meaning you understand the study and agree to join.
  • Have lupus that meets the study’s medical rules for diagnosis.
  • If you had kidney disease before, it must now be in remission, meaning it is not causing active signs. Your current urine protein-to-creatinine ratio (UPCR), a measure of protein in urine, must be below 0.3.
  • If you have never had kidney disease, your lupus must have been diagnosed within the past 5 years. You must have a positive anti-dsDNA blood test or low C3 or C4 blood levels, which are signs of immune system activity. Your current UPCR must be below 0.3.
  • Own a mobile phone.
  • Be enrolled in the SAMPLE Biorepository (s14-00487).

Who can't join

  • Be unwilling or unable to take part.
  • The study doctor believes you do not understand the consent form.
  • Speak a language other than English, Spanish, or Mandarin.
  • Do not own a mobile phone.
  • Are not enrolled in the SAMPLE Biorepository (s14-00487).

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 sites (1)

NY