Simple urine test could spare lupus patients painful kidney biopsies

NCT ID NCT06642402

Diagnosis Sponsor: Kolding Sygehus Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing whether a urine test can detect lupus nephritis, a serious kidney complication of lupus, as accurately as a standard kidney biopsy. Researchers will collect urine and blood samples from 40 lupus patients with kidney problems and compare the results to their biopsy findings. If the urine test works, it could offer a less invasive way to diagnose and monitor the disease.

What this could mean

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

Active substance: Urinary extracellular vesicle testing
What this could lead to: If successful, this could lead to a simple urine test to diagnose and monitor lupus nephritis without needing an invasive kidney biopsy.
What could go wrong: This is a small, early-stage study with only 40 participants, so results may not apply to all patients. The urine test may not match the accuracy of a biopsy.

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Study facts

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

Participants

About 40 people

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

Started

Nov 2024

Expected to finish

May 2030

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

Patients known with SLE with and without kidney involvement, a biopsy control and a group of healthy controls.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

SLE patients with kidney involvement Inclusion criteria: * \> 18 years old * Fulfilling the 2019 EULAR/ACR classification criteria * Positive autoantibodies, medical history and obejctive examination compatible with SLE * Referred to kidney biopsy Exclusion criteria: * Lack of ability or willingness to provide informed consent * Significant comorbidity, which is considered to potentially impact the outcome SLE patients with no sign of kidney disease Inclusion criteria: * \> 18 years old * Fulfilling the 2019 EULAR/ACR classification criteria * Positive autoantibodies, medical history and obejctive examination compatible with SLE * Normal plasma creatinine * Urine albumine/creatinine \< 100 mg/g Exclusion criteria: * Lack of ability or willingness to provide informed consent * Significant comorbidity, which is considered to potentially impact the outcome Healthy controls: Inclusion criteria: * \> 18 years old * No known kidney disease Exclusion criteria: * Lack of ability or willingness to provide informed consent * Urine albumin-creatinine ratio \> 100 mg/g or proteinuria \> 100 mg/day * Postive autoantibodies * Significant comorbidity, which is considered to potentially impact the outcome Biopsy control: Inclusion criteria: * \> 18 years old * Negative autoantibiodies and immunoglobulines * Referred to kidney biopsy Exclusion criteria: * Lack of ability or willingness to provide informed consent * Significant comorbidity, which is considered to potentially impact the outcome

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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.

Systemic lupus erythematosus nephritis

How to take part

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

The places running it

4 sites. The list below names each one and where it is.
The official record

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

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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.

Simple urine test could spare lupus patients painful kidney biopsies

What the study statuses mean