Blood test may spot lupus kidney damage early, reducing need for biopsies
NCT ID NCT07505576
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
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can bone marrow stem cells calm lupus kidney flares?
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