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New biomarker study aims to spot lupus kidney disease earlier

NCT ID NCT07666711

Knowledge-focused Sponsor: Oslo University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study follows 500 adults with lupus to see if blood and urine tests can reliably detect kidney inflammation (lupus nephritis). Participants give samples during routine visits, and doctors track their kidney health over time. The goal is to find simple, non-invasive markers that could replace or reduce the need for kidney biopsies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could lead to better, non-invasive tests to detect and monitor kidney inflammation in lupus patients, reducing the need for repeated biopsies.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear biomarker patterns, and results may not apply to all lupus patients or other hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus nephritis Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Oslo, Oslo, 0372, Norway

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