Biomarker Development for Autoimmune Disorders Involving the Kidneys
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Longitudinal Blood and Urine Biomarker Monitoring
Diagnostic testAll 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Adults With Systemic Lupus Erythematosus1 intervention
Trial outcomes
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.
Time frame
From enrollment through study completion, assessed up to 5 years.Secondary outcomes
1
Area Under the Receiver Operating Characteristic Curve of the Urinary Biomarker Score for Active Lupus Nephritis
AUC of a pre-specified urinary biomarker score for distinguishing active lupus nephritis from inactive lupus nephritis or systemic lupus erythematosus without renal involvement. The urinary biomarker score will be calculated from pre-specified urine biomarker concentrations according to the statistical analysis plan. The AUC will be reported as a unitless value with 95% confidence interval.
Time frame
From enrollment through study completion, assessed up to 5 years.2
Area Under the Receiver Operating Characteristic Curve of the Blood Biomarker Score for Active Lupus Nephritis
AUC of a pre-specified blood biomarker score for distinguishing active lupus nephritis from inactive lupus nephritis or systemic lupus erythematosus without renal involvement. The blood biomarker score will be calculated from pre-specified blood biomarker concentrations according to the statistical analysis plan. The AUC will be reported as a unitless value with 95% confidence interval.
Time frame
From enrollment through study completion, assessed up to 5 years.3
Sensitivity of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
Sensitivity of the pre-specified combined blood-and-urine biomarker score cut-off for identifying active lupus nephritis. Sensitivity will be reported as the percentage of participants with active lupus nephritis who have a biomarker score above the pre-specified cut-off.
Time frame
From enrollment through study completion, assessed up to 5 years.4
Specificity of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
Specificity of the pre-specified combined blood-and-urine biomarker score cut-off for identifying active lupus nephritis. Specificity will be reported as the percentage of participants without active lupus nephritis who have a biomarker score below the pre-specified cut-off.
Time frame
From enrollment through study completion, assessed up to 5 years.Sponsors and contacts
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Source ClinicalTrials.gov