HEALTH Home Urinalysis Testing
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Home Urine Testing
Procedure/SurgeryParticipants 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Weekly Home-Based Proteinuria TestingExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
Source ClinicalTrials.gov