Lupus NephritisSILENT_LNNCT07666711
Biomarker Development for Autoimmune Disorders Involving the Kidneys
An observational study of Lupus Nephritis and Systemic Lupus Erythematosus, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Nephritis, Systemic Lupus Erythematosus
- What is being tested?
- Longitudinal Blood and Urine Biomarker Monitoring
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jun 2026to 14 Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo universitetssykehus HF, Rikshospitalet, Clinic for Surgery and Specialized Medicine, Department of Rheumatology, Skin and Infectious Diseases
Oslo, Oslo, 0372
Simin Jamaly, PhD, +4746949074, simjam@ous-hf.no
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus
- Being tested
- Longitudinal Blood and Urine Biomarker Monitoring
- Keywords
- Systemic lupus erythematosus, SLE, Lupus nephritis, LN, Autoimmune kidney disease, Blood biomarkers, Urine biomarkers, Renal flare, Incident lupus nephritis, Active lupus nephritis, Treatment response, Renal remission, Kidney biopsy, Biomarker panel, Longitudinal monitoring
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal Blood and Urine Biomarker MonitoringDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Longitudinal Blood and Urine Biomarker Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through study completion, assessed up to 5 years.
Secondary outcomes (12)
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.
Measured: From enrollment through study completion, assessed up to 5 years.
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.
Measured: From enrollment through study completion, assessed up to 5 years.
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.
Measured: From enrollment through study completion, assessed up to 5 years.
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.
Measured: From enrollment through study completion, assessed up to 5 years.
Positive Predictive Value of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
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.
Measured: From enrollment through study completion, assessed up to 5 years.
Negative Predictive Value of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
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.
Measured: From enrollment through study completion, assessed up to 5 years.
Area Under the Receiver Operating Characteristic Curve of the Combined Blood-and-Urine Biomarker Score for Incident Lupus Nephritis
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.
Measured: From enrollment until incident lupus nephritis, loss to follow-up, or study completion, assessed up to 5 years.
Change in Combined Blood-and-Urine Biomarker Score From Inactive Renal Disease to Active Lupus Nephritis or Renal Flare
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.
Measured: From inactive renal disease or no renal involvement visit to active lupus nephritis or renal flare visit, assessed up to 5 years.
Change in Combined Blood-and-Urine Biomarker Score From Active Lupus Nephritis or Renal Flare to Renal Response or Remission
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.
Measured: From active lupus nephritis or renal flare visit to renal response, remission, or inactive renal disease visit, assessed up to 5 years.
Percentage of Participants With Active Lupus Nephritis Achieving Renal Response or Remission
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.
Measured: From active lupus nephritis or renal flare visit through study completion, assessed up to 5 years.
Correlation Between Combined Blood-and-Urine Biomarker Score and Kidney Biopsy Activity Index
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.
Measured: At kidney biopsy or re-biopsy visit, assessed up to 5 years.
Cumulative Incidence of Incident Lupus Nephritis
Percentage of participants without lupus nephritis at enrollment who develop incident lupus nephritis during follow-up.
Measured: Up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion14 Jun 2031 (estimated)
- Study completion14 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simin Jamaly, Oslo University Hospital
- Investigators
- Simin Jamaly, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666711
- Sponsor's protocol ID
- 722021
- Acronym
- SILENT_LN
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. Access to de-identified data may be considered upon reasonable request and will be subject to ethical approvals, data protection regulations, institutional policies, and data sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Development for Autoimmune Disorders Involving the Kidneys
- ClinicalTrials.gov ID
- NCT07666711
- Acronym / sponsor ID
- SILENT_LN / 722021
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, SLE, Lupus nephritis, LN, Autoimmune kidney disease, Blood biomarkers, Urine biomarkers, Renal flare
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 14 Jun 2031 (estimated)
- Study completion
- 14 Jun 2031 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Systemic Lupus Erythematosus | – | Diagnostic Test: Longitudinal Blood and Urine Biomarker MonitoringAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitudinal Blood and Urine Biomarker MonitoringAll 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. | Diagnostic test | Adults With Systemic Lupus Erythematosus |
Primary outcome
Area Under the Receiver Operating Characteristic Curve of the Combined Blood-and-Urine Biomarker Score for Active Lupus Nephritis
Time frame: From enrollment through study completion, assessed up to 5 years.
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.
12 secondary outcomes
Area Under the Receiver Operating Characteristic Curve of the Urinary Biomarker Score for Active Lupus Nephritis
Time frame: From enrollment through study completion, assessed up to 5 years.
Area Under the Receiver Operating Characteristic Curve of the Blood Biomarker Score for Active Lupus Nephritis
Time frame: From enrollment through study completion, assessed up to 5 years.
Sensitivity of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
Time frame: From enrollment through study completion, assessed up to 5 years.
Specificity of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
Time frame: From enrollment through study completion, assessed up to 5 years.
Positive Predictive Value of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
Time frame: From enrollment through study completion, assessed up to 5 years.
Negative Predictive Value of the Combined Blood-and-Urine Biomarker Score Cut-Off for Active Lupus Nephritis
Time frame: From enrollment through study completion, assessed up to 5 years.
Area Under the Receiver Operating Characteristic Curve of the Combined Blood-and-Urine Biomarker Score for Incident Lupus Nephritis
Time frame: From enrollment until incident lupus nephritis, loss to follow-up, or study completion, assessed up to 5 years.
Change in Combined Blood-and-Urine Biomarker Score From Inactive Renal Disease to Active Lupus Nephritis or Renal Flare
Time frame: From inactive renal disease or no renal involvement visit to active lupus nephritis or renal flare visit, assessed up to 5 years.
Change in Combined Blood-and-Urine Biomarker Score From Active Lupus Nephritis or Renal Flare to Renal Response or Remission
Time frame: From active lupus nephritis or renal flare visit to renal response, remission, or inactive renal disease visit, assessed up to 5 years.
Percentage of Participants With Active Lupus Nephritis Achieving Renal Response or Remission
Time frame: From active lupus nephritis or renal flare visit through study completion, assessed up to 5 years.
Correlation Between Combined Blood-and-Urine Biomarker Score and Kidney Biopsy Activity Index
Time frame: At kidney biopsy or re-biopsy visit, assessed up to 5 years.
Cumulative Incidence of Incident Lupus Nephritis
Time frame: Up to 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Oslo University Hospital- clinic studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. Access to de-identified data may be considered upon reasonable request and will be subject to ethical approvals, data protection regulations, institutional policies, and data sharing agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simin Jamaly, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis and Systemic Lupus Erythematosus, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simin Jamaly, PhD (+4746949074, simjam@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve of the Combined Blood-and-Urine Biomarker Score for Active Lupus Nephritis (time frame: From enrollment through study completion, assessed up to 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.