Study of Blood and Urine Biomarkers for Kidney Involvement in Adults with Systemic Lupus Erythematosus Tracking Lupus Nephritis Activity, Treatment Response, and Outcomes Over 5 Years

What this Trial Is About

Researchers are conducting a prospective observational study called SILENT-LN to understand kidney involvement in adults with systemic lupus erythematosus SLE. The study includes adults with no kidney involvement, suspected kidney problems, active lupus nephritis, previous lupus nephritis, or inactive lupus nephritis. It aims to evaluate blood and urine biomarkers to track active kidney disease, onset of lupus nephritis, flares, treatment responses, remission, biopsy findings, and long-term kidney outcomes. Participants will receive routine clinical care while providing blood and urine samples over up to 5 years. Biomarker levels will be measured serially and analyzed individually and as combined panel scores. If biomarkers show persistent elevation or increase, a structured kidney assessment may be triggered, and kidney biopsy or re-biopsy might be done if medically appropriate and agreed upon by the participant. Clinical data, lab tests, disease activity, treatments, and biopsy results will be collected alongside biomarker data. During the study, participants will have blood and urine samples taken at routine visits and when kidney involvement is suspected. Clinical assessments, standard labs, kidney function tests, and disease activity measures will also be recorded. Researchers will track biomarker accuracy for active lupus nephritis and other outcomes over time. The study includes ongoing safety monitoring, and participation may last up to 5 years, with data collected during usual clinical follow-ups.

Biomarker Development for Autoimmune Disorders Involving the Kidneys