Biomarker tests in adults with lupus to see how kidney disease changes over time

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational cohort study enrolling adults with systemic lupus erythematosus, including those with and without current kidney involvement. Participants will provide blood and urine samples at regular visits and when kidney concerns arise, alongside standard clinical data. The study aims to see if biomarker levels and panels correlate with active lupus nephritis, incident nephritis, renal flare, treatment response, remission, biopsy findings, and long-term kidney outcomes over up to five years. Analyses will consider subgroups such as those without nephritis at baseline, those with suspected or active nephritis, and those undergoing biopsy when biomarker changes occur. The goal is to identify biomarker patterns that could guide future diagnostic and monitoring approaches in lupus-related kidney disease.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Simin Jamaly, PhD — Oslo University Hospital
• Study coordinator: Simin Jamaly, PhD
• Email: simjam@ous-hf.no
• Phone: +4746949074

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.