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Blood test may spot lupus kidney damage early, reducing need for biopsies

NCT ID NCT07505576

What the study statuses mean

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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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 Results may not be published yet.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.
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Cancelled before anyone took part.

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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

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Status unknown
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First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether measuring anti-alpha-actinin antibodies in the blood can help identify active lupus nephritis (kidney inflammation) in people with lupus. Researchers will compare antibody levels with findings from standard kidney biopsies in 96 adults. If the blood test works well, it could become a simpler, less invasive way to monitor kidney disease.

What this could mean

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

Active substance
serum anti-alpha-actinin antibodies (diagnostic test)
What this could lead to
If successful, this blood test could help doctors detect active lupus nephritis earlier and more easily, potentially reducing the need for invasive kidney biopsies.
What could go wrong
This is an early, observational study with only 96 participants. The antibody test may not prove accurate enough to replace biopsies, and results may not apply to all lupus patients.

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 96 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

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

1. Inclusion criteria for LN group: 1. Adult patients (≥ 18 and \> 60 years) of either sex. 2. Fulfill the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus (SLE) \[11\]. 3. Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g/24h, active urinary sediment, unexplained rise in serum creatinine). 2. Exclusion criteria: Participants will be excluded if ANY of the following criteria apply: 1. Other Kidney Diseases: * Presence of, or suspicion of, any other primary or significant secondary kidney disease unrelated to SLE (e.g., diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, significant drug-induced nephrotoxicity, rheumatoid arthritis, positive HBs antigen or HCV antibody). 2. Confounding Clinical Conditions: * Presence of an active or recent major infection (e.g., sepsis, pneumonia, UTI) at the time of enrollment, as infection can significantly alter immune markers.

Ages

18 to 60 years

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.

Inclusion Criteria: 1. Inclusion criteria for LN group: 1. Adult patients (≥ 18 and \> 60 years) of either sex. 2. Fulfill the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus (SLE). 3. Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g/24h, active urinary sediment, unexplained rise in serum creatinine). 4. Availability of an adequate renal biopsy specimen for histopathological evaluation according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2018 classification. 5. Renal biopsy performed within 3 months prior to enrollment, and patient has not received induction immunosuppressive therapy (cyclophosphamide, mycophenolate mofetil, or calcineurin inhibitors) in the period between biopsy and enrollment. 6. Provision of written informed consent. b)Inclusion Criteria for Control Groups: <!-- --> 1. SLE without nephritis: Patients meeting SLE criteria without any clinical or laboratory evidence of renal involvement (normal urinalysis, proteinuria \< 0.3 g/24h, normal serum creatinine). 2. Healthy controls: Age- and sex-matched healthy individuals with no history of autoimmune disease, normal urinalysis, and negative autoantibodies (ANA, anti-dsDNA). Exclusion Criteria: \- Participants will be excluded if ANY of the following criteria apply: <!-- --> 1. Other Kidney Diseases: * Presence of, or suspicion of, any other primary or significant secondary kidney disease unrelated to SLE (e.g., diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, significant drug-induced nephrotoxicity, rheumatoid arthritis, positive HBs antigen or HCV antibody). 2. Confounding Clinical Conditions: * Presence of an active or recent major infection (e.g., sepsis, pneumonia, UTI) at the time of enrollment, as infection can significantly alter immune markers. * Presence of advanced chronic kidney disease (CKD Stage 4 or 5) predating the diagnosis of SLE. * Pregnancy or lactation. 3. Confounding Medications: * Receipt of high-dose corticosteroids (\> 20 mg/day of prednisone or equivalent) or any potent immunosuppressive agent (e.g., cyclophosphamide, mycophenolate mofetil, rituximab) within 4 weeks prior to the renal biopsy and blood sampling).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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