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Biomarker Development for Autoimmune Disorders Involving the Kidneys

NCT07666711 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-06-29

No results posted yet for this study

Summary

SILENT-LN is a prospective observational cohort study of adults with systemic lupus erythematosus, including participants with no renal involvement, suspected renal involvement, active lupus nephritis, previous lupus nephritis, or inactive lupus nephritis. The study will measure pre-specified blood and urine biomarkers longitudinally during routine clinical care.

The study will evaluate whether blood and urine biomarker concentrations and biomarker panel scores are associated with active lupus nephritis, incident lupus nephritis, renal flare, treatment response, remission or inactive renal disease, kidney biopsy findings, and long-term renal outcomes.

Participants will provide blood and urine samples during routine clinical follow-up visits and at visits where renal involvement is clinically suspected. Clinical data, standard laboratory tests, disease activity assessments, kidney function measures, treatment information, and kidney biopsy findings, when available, will be recorded.

A predefined increase or persistent elevation in blood or urine biomarker levels will trigger a structured renal assessment, and kidney biopsy or re-biopsy may be performed if the integrated clinical assessment indicates suspected renal involvement, renal flare, or uncertainty regarding renal inflammatory activity and the procedure is considered safe and clinically appropriate.

The study is currently conducted at Oslo University Hospital, Riks Hospital and may expand to additional centers following funding and regulatory approvals.

Conditions

Interventions

DIAGNOSTIC_TEST

Longitudinal Blood and Urine Biomarker Monitoring

All enrolled adults with systemic lupus erythematosus, with or without renal involvement, will undergo serial blood and urine biomarker monitoring during routine follow-up. Biomarker concentrations and panel scores will be analyzed in relation to renal disease status, including incident lupus nephritis, active or inactive lupus nephritis, renal flare, treatment response, remission, biopsy findings, and renal outcomes. Biomarker increase or persistent elevation may trigger structured renal assessment. Kidney biopsy or re-biopsy may be considered after integrated medical assessment if lupus nephritis activity is suspected or uncertain and the procedure is safe, appropriate, and accepted by the participant. Treatment decisions remain under the responsibility of the treating physician.

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Simin Jamaly, PhD · Oslo University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2031-06-14
Completion
2031-06-14

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07666711 on ClinicalTrials.gov