Biomarker Development for Autoimmune Disorders Involving the Kidneys

NCT07666711 | Recruiting

• 1 other identifier: 722021
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Lupus Nephritis; Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosus; SLE; Lupus nephritis; LN; Autoimmune kidney disease; Blood biomarkers; Urine biomarkers; Renal flare; Incident lupus nephritis; Active lupus nephritis; Treatment response; Renal remission; Kidney biopsy; Biomarker panel; Longitudinal monitoring

Outcome Measures

Primary Outcomes (1)

• Area Under the Receiver Operating Characteristic Curve of the Combined Blood-and-Urine Biomarker Score for Active Lupus Nephritis

  Area under the receiver operating characteristic curve, AUC, of the pre-specified combined blood-and-urine biomarker score for distinguishing active lupus nephritis from inactive lupus nephritis or systemic lupus erythematosus without renal involvement. The combined biomarker score will be calculated from pre-specified blood and urine biomarker concentrations according to the statistical analysis plan. Active lupus nephritis status will be defined according to predefined clinical criteria and kidney biopsy findings when available. The AUC will be reported as a unitless value with 95% confidence interval.

  From enrollment through study completion, assessed up to 5 years.

Secondary Outcomes (12)

• Area Under the Receiver Operating Characteristic Curve of the Urinary Biomarker Score for Active Lupus Nephritis

  From enrollment through study completion, assessed up to 5 years.

• Area Under the Receiver Operating Characteristic Curve of the Blood Biomarker Score for Active Lupus Nephritis

  From enrollment through study completion, assessed up to 5 years.

• Sensitivity of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis

  From enrollment through study completion, assessed up to 5 years.

• Specificity of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis

  From enrollment through study completion, assessed up to 5 years.

• Positive Predictive Value of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis

  From enrollment through study completion, assessed up to 5 years.

Study Arms (1)

Adults With Systemic Lupus Erythematosus

Adults with systemic lupus erythematosus receiving routine clinical care at Oslo University Hospital or another participating center. Participants may have no renal involvement, suspected renal involvement, active lupus nephritis, previous lupus nephritis, newly diagnosed lupus nephritis, inactive lupus nephritis, or lupus nephritis in remission. Participants will be followed prospectively with longitudinal blood and urine sampling, clinical assessment, standard laboratory testing, treatment data collection, and recording of kidney biopsy findings when clinically available.

Diagnostic Test: Longitudinal Blood and Urine Biomarker Monitoring

Interventions

Longitudinal Blood and Urine Biomarker Monitoring DIAGNOSTIC_TEST

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.

Adults With Systemic Lupus Erythematosus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults with systemic lupus erythematosus receiving routine clinical care at Oslo University Hospital or another participating center. Participants may have no renal involvement, suspected renal involvement, active lupus nephritis, previous lupus nephritis, newly diagnosed lupus nephritis, inactive lupus nephritis, or lupus nephritis in remission. Participants will be recruited from the NOSVAR cohort and associated rheumatology outpatient clinics. The cohort will be followed prospectively with longitudinal collection of clinical data, standard laboratory data, treatment information, blood samples, urine samples, and kidney biopsy findings when clinically available.

You may qualify if:

• Age 18 years or older
• Established diagnosis of systemic lupus erythematosus according to accepted classification criteria
• Receiving routine clinical care at Oslo University Hospital or another participating center
• Able to provide informed consent according to the approved consent procedure
• Willing and able to provide blood and/or urine samples for biomarker analysis
• For the biopsy-validation analysis population: predefined increase or persistent elevation in one or more blood or urine biomarkers prompting structured renal assessment, with integrated medical assessment indicating suspected renal involvement, possible renal flare, unresolved uncertainty regarding renal inflammatory activity, or discordance between biomarker findings and conventional clinical measures

You may not qualify if:

• Inability to provide valid informed consent, unless an approved alternative consent procedure applies
• Known kidney disease not related to systemic lupus erythematosus that would prevent interpretation of lupus nephritis-related biomarker findings
• Previous kidney transplantation
• Active infection or acute medical instability that would interfere with study procedures or interpretation of biomarker findings in the time of sampling
• For the biopsy-validation analysis population: kidney biopsy or re-biopsy is considered unsafe or inappropriate by the treating specialist
• For the biopsy-validation analysis population: contraindication to native kidney biopsy according to local hospital procedures or specialist assessment
• For the biopsy-validation analysis population: participant declines kidney biopsy, re-biopsy, or participation in the biopsy-validation component

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo universitetssykehus HF, Rikshospitalet, Clinic for Surgery and Specialized Medicine, Department of Rheumatology, Skin and Infectious Diseases

Oslo, Oslo, 0372, Norway

RECRUITING

Related Links

• Oslo University Hospital- clinic study

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Simin Jamaly, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simin Jamaly, PhD

CONTACT

+4746949074; simjam@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, Department of Rheumatology, Dermatology and Infectious Diseases

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 24, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 14, 2031
• Study Completion (Estimated): June 14, 2031
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)