NCT07666711 Biomarker Development for Autoimmune Disorders Involving the Kidneys
| NCT ID | NCT07666711 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Lupus Nephritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2031-06-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-06-15 with a primary completion date of 2031-06-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Simin Jamaly, PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT07666711 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lupus Nephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07666711 currently recruiting?
Yes, NCT07666711 is actively recruiting participants. Contact the research team at simjam@ous-hf.no for enrollment information.
Where is the NCT07666711 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT07666711 clinical trial?
NCT07666711 is sponsored by Oslo University Hospital. The principal investigator is Simin Jamaly, PhD at Oslo University Hospital. The trial plans to enroll 500 participants.
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