Biomarker Development for Autoimmune Disorders Involving the Kidneys (SILENT_LN)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
SILENT-LN is a prospective observational longitudinal biomarker study in adults with systemic lupus erythematosus receiving routine clinical care. The study includes participants with and without renal involvement at enrollment. Participants will be followed for up to 5 years with serial collection of blood samples, urine samples, standard clinical data, routine laboratory data, treatment information, and kidney biopsy findings when clinically available.
The study includes the following pre-specified analysis populations:
Participants with systemic lupus erythematosus without lupus nephritis at enrollment, followed for incident or new-onset lupus nephritis.
Participants with suspected renal involvement or active lupus nephritis, evaluated for association between biomarker levels and active renal disease.
Participants with established or newly diagnosed lupus nephritis, followed longitudinally for renal flare, treatment response, remission or inactive renal disease, and long-term renal outcomes.
Participants undergoing biomarker-triggered renal assessment, in whom kidney biopsy or re-biopsy may be performed when biomarker elevation is accompanied by suspected renal involvement, possible renal flare, unresolved uncertainty regarding renal inflammatory activity, or discordance between biomarker findings and conventional clinical measures, provided that biopsy is considered safe and appropriate by the treating specialist.
Blood and urine biomarker concentrations will be measured using pre-specified laboratory assays. Biomarker results may be analyzed as individual biomarker concentrations and as pre-specified biomarker panel scores. When blood and urine biomarkers are combined, they will be aggregated into a pre-specified composite score according to the statistical analysis plan.
Active lupus nephritis, incident lupus nephritis, renal flare, treatment response, remission, and inactive renal disease will be defined according to predefined protocol criteria based on routine clinical assessment, urinalysis, proteinuria, kidney function, serological markers, disease activity assessment, treatment status, and kidney biopsy findings when available.
The study includes a biomarker-triggered renal assessment pathway. A predefined increase or persistent elevation in one or more blood or urine biomarkers will prompt a structured medical assessment for possible renal involvement or renal inflammatory activity. This assessment will integrate biomarker results with conventional clinical and laboratory information, including symptoms, urinalysis, proteinuria, urinary sediment, serum creatinine, estimated glomerular filtration rate, complement levels, anti-dsDNA antibodies, SLE disease activity, medication exposure, and treating physician assessment.
Kidney biopsy or re-biopsy may be performed when the integrated assessment indicates suspected lupus nephritis, possible renal flare, unresolved uncertainty regarding renal inflammatory activity, or discordance between biomarker findings and conventional clinical measures. Biopsy or re-biopsy will only be performed if the treating specialist considers the procedure safe and appropriate and the participant agrees to the procedure. Biomarker elevation alone will trigger medical assessment but will not automatically mandate biopsy.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Simin Jamaly, PhD
- Número de telefone: +4746949074
- E-mail: simjam@ous-hf.no
Locais de estudo
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Oslo
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Oslo, Oslo, Noruega, 0372
- Recrutamento
- Oslo universitetssykehus HF, Rikshospitalet, Clinic for Surgery and Specialized Medicine, Department of Rheumatology, Skin and Infectious Diseases
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Contato:
- Simin Jamaly, PhD
- Número de telefone: +4746949074
- E-mail: simjam@ous-hf.no
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Area Under the Receiver Operating Characteristic Curve of the Combined Blood-and-Urine Biomarker Score for Active Lupus Nephritis
Prazo: From enrollment through study completion, assessed up to 5 years.
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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.
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From enrollment through study completion, assessed up to 5 years.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Area Under the Receiver Operating Characteristic Curve of the Urinary Biomarker Score for Active Lupus Nephritis
Prazo: From enrollment through study completion, assessed up to 5 years.
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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.
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From enrollment through study completion, assessed up to 5 years.
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Area Under the Receiver Operating Characteristic Curve of the Blood Biomarker Score for Active Lupus Nephritis
Prazo: From enrollment through study completion, assessed up to 5 years.
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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.
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From enrollment through study completion, assessed up to 5 years.
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Sensitivity of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
Prazo: From enrollment through study completion, assessed up to 5 years.
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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.
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From enrollment through study completion, assessed up to 5 years.
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Specificity of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
Prazo: From enrollment through study completion, assessed up to 5 years.
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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.
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From enrollment through study completion, assessed up to 5 years.
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Positive Predictive Value of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
Prazo: From enrollment through study completion, assessed up to 5 years.
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Positive predictive value of the pre-specified combined blood-and-urine biomarker score cut-off for identifying active lupus nephritis.
Positive predictive value will be reported as the percentage of participants with a biomarker score above the pre-specified cut-off who have active lupus nephritis.
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From enrollment through study completion, assessed up to 5 years.
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Negative Predictive Value of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
Prazo: From enrollment through study completion, assessed up to 5 years.
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Negative predictive value of the pre-specified combined blood-and-urine biomarker score cut-off for identifying active lupus nephritis.
Negative predictive value will be reported as the percentage of participants with a biomarker score below the pre-specified cut-off who do not have active lupus nephritis.
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From enrollment through study completion, assessed up to 5 years.
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Area Under the Receiver Operating Characteristic Curve of the Combined Blood-and-Urine Biomarker Score for Incident Lupus Nephritis
Prazo: From enrollment until incident lupus nephritis, loss to follow-up, or study completion, assessed up to 5 years.
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AUC of the pre-specified combined blood-and-urine biomarker score for prediction of incident lupus nephritis among participants without lupus nephritis at enrollment.
Incident lupus nephritis is defined as the first occurrence of lupus nephritis during follow-up according to predefined clinical criteria and kidney biopsy findings when available.
The AUC will be reported as a unitless value with 95% confidence interval.
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From enrollment until incident lupus nephritis, loss to follow-up, or study completion, assessed up to 5 years.
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Change in Combined Blood-and-Urine Biomarker Score From Inactive Renal Disease to Active Lupus Nephritis or Renal Flare
Prazo: From inactive renal disease or no renal involvement visit to active lupus nephritis or renal flare visit, assessed up to 5 years.
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Within-participant change in the combined blood-and-urine biomarker score between a visit classified as inactive renal disease or no renal involvement and a subsequent visit classified as active lupus nephritis or renal flare.
Change will be reported in biomarker score units.
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From inactive renal disease or no renal involvement visit to active lupus nephritis or renal flare visit, assessed up to 5 years.
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Change in Combined Blood-and-Urine Biomarker Score From Active Lupus Nephritis or Renal Flare to Renal Response or Remission
Prazo: From active lupus nephritis or renal flare visit to renal response, remission, or inactive renal disease visit, assessed up to 5 years.
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Within-participant change in the combined blood-and-urine biomarker score between a visit classified as active lupus nephritis or renal flare and a subsequent visit classified as renal response, remission, or inactive renal disease.
Change will be reported in biomarker score units.
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From active lupus nephritis or renal flare visit to renal response, remission, or inactive renal disease visit, assessed up to 5 years.
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Percentage of Participants With Active Lupus Nephritis Achieving Renal Response or Remission
Prazo: From active lupus nephritis or renal flare visit through study completion, assessed up to 5 years.
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Percentage of participants with active lupus nephritis or renal flare who achieve renal response, remission, or inactive renal disease during follow-up according to predefined protocol criteria based on proteinuria, kidney function, urinalysis, disease activity assessment, treatment status, and treating physician assessment.
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From active lupus nephritis or renal flare visit through study completion, assessed up to 5 years.
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Correlation Between Combined Blood-and-Urine Biomarker Score and Kidney Biopsy Activity Index
Prazo: At kidney biopsy or re-biopsy visit, assessed up to 5 years.
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Correlation between the combined blood-and-urine biomarker score measured at the kidney biopsy or re-biopsy visit and the kidney biopsy activity index.
The correlation will be reported as a correlation coefficient.
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At kidney biopsy or re-biopsy visit, assessed up to 5 years.
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Cumulative Incidence of Incident Lupus Nephritis
Prazo: Up to 5 years.
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Percentage of participants without lupus nephritis at enrollment who develop incident lupus nephritis during follow-up.
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Up to 5 years.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Simin Jamaly, PhD, Oslo University Hospital
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Urogenitais Masculinas
- Doenças renais
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças do Tecido Conjuntivo
- Doenças autoimunes
- Doenças do sistema imunológico
- Glomerulonefrite
- Nefrite
- Doenças da Pele e do Tecido Conjuntivo
- Lúpus Eritematoso Sistêmico
- Doença de Lupus
Outros números de identificação do estudo
- 722021
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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