Lupus Trial, Recruiting NCT06642402 Sponsor: Kolding Sygehus Condition: Lupus
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Lupus Trial, Recruiting

NCT06642402
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

This trial has four different groups. A person may fit into one of the following:

Group 1 – People with lupus (SLE) and kidney involvement:

  • Adults aged 18 or older
  • Diagnosed with lupus (SLE) based on recognised 2019 international classification criteria
  • Has positive autoantibodies (specific proteins the immune system makes that can indicate lupus), along with a medical history and physical examination consistent with lupus
  • Has been referred for a kidney biopsy (a procedure where a small sample of kidney tissue is taken for testing)

Group 2 – People with lupus (SLE) and no signs of kidney disease:

  • Adults aged 18 or older
  • Diagnosed with lupus (SLE) based on recognised 2019 international classification criteria
  • Has positive autoantibodies, along with a medical history and physical examination consistent with lupus
  • Has normal kidney function levels in the blood
  • Has low levels of protein in the urine, indicating the kidneys are not leaking protein

Group 3 – Healthy volunteers:

  • Adults aged 18 or older
  • No known kidney disease

Group 4 – Biopsy control group (people having a kidney biopsy for reasons other than lupus):

  • Adults aged 18 or older
  • Does not have positive autoantibodies or abnormal immunoglobulins (certain immune system proteins)
  • Has been referred for a kidney biopsy

Who may not be able to join:

Applies to all groups:

  • People who are unable or unwilling to give informed consent to participate in the study
  • People with serious other health conditions that doctors consider could affect the study results

Additional exclusions for healthy volunteers (Group 3):

  • People who have abnormal levels of protein in their urine, which may suggest a kidney problem
  • People who have positive autoantibodies

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Anne F Christensen, Chief of Medicine, MD, phd, Sygehus Lillebaelt, Kolding Hospitl

Phone: 4530281347

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Kolding Sygehus
Registry
ClinicalTrials.gov
Start date
15 November 2024
Est. completion
1 May 2029

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Correlation between kidney biopsy and urinay extracellular vesicles; Complement activation in urinary extracellular vesicles

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov