Clinical trial for Systemic Lupus Erythematosus
Official title HEALTH Home Urinalysis Testing
ClinicalTrials.gov ID: NCT07823478
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join 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...
- If the patient does not own a mobile phone
- Patient not enrolled in SAMPLE Biorepository (s14-00487)
See the full eligibility 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...
- 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...
- Ownership of any mobile phone.
- Must be enrolled in SAMPLE Biorepository (s14-00487)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.