NCT07666711Recruiting
Biomarker Development for Autoimmune Disorders Involving the Kidneys
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 5 Jun 2026
- Start date
- 15 Jun 2026
- Primary completion date
- 14 Jun 2031
- Lead sponsor
- Oslo University Hospital
- Diseases
- Lupus (SLE)
- NCT number
- NCT07666711
What you commit to
- Study type: Observational
- Planned participants: 500
- From 15 Jun 2026 to the primary completion date, 14 Jun 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous kidney transplantation
Other illness
- Known kidney disease not related to systemic lupus erythematosus that would prevent interpretation of lupus nephritis-related biomarker findings
- Active infection or acute medical instability that would interfere with study procedures or interpretation of biomarker findings in the time of sampling
Other
- Inability to provide valid informed consent, unless an approved alternative consent procedure applies
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo universitetssykehus HF, Rikshospitalet, Clinic for Surgery and Specialized Medicine, Department of Rheumatology, Skin and Infectious Diseases Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.