Urinary extracellular vesicle monitoring for lupus nephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study that compares urinary extracellular vesicle (uEV) profiles with kidney biopsy findings and blood autoimmunity markers in adults with SLE. Participants include SLE patients referred for kidney biopsy, SLE patients without kidney involvement, and healthy controls. Researchers will collect urine, plasma, and biopsy samples and analyze uEV content and complement-related signals to see whether uEV patterns match ISN/RPS histopathology classes or signs of active renal injury. The goal is to determine whether uEVs could serve as a non-invasive liquid biopsy reflecting the pattern or severity of lupus-related kidney damage.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Rheumatology
  Odense, Denmark Recruiting
• Kolding Hospital
  Kolding, Denmark Not yet recruiting
• Department of Nephrology
  Odense, Denmark Not yet recruiting
• Univesity of Southern Denmark
  Odense, Denmark Not yet recruiting

Study contacts

• Study coordinator: Rikke Z Langkilde, MD, phd
• Email: rikke.zachar.langkilde@rsyd.dk
• Phone: 4530281347

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.