Urinary extracellular vesicle monitoring for lupus nephritis
Monitoring and Detecting Lupus Nephritis Through Urinary Extracellular Vesicles in Urine
This project will test whether measuring tiny particles in urine (urinary extracellular vesicles) can help detect and monitor kidney inflammation in adults with lupus nephritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kolding Sygehus Academic / other |
| Locations | 4 sites (Kolding and 3 other locations) |
| Trial ID | NCT06642402 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (over 18) with SLE who are being referred for kidney biopsy, along with SLE patients without kidney signs and healthy volunteers for comparison.
Not a fit: People without SLE, children under 18, or patients with major comorbidities that affect kidney outcomes are unlikely to benefit from this research.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive way to detect and monitor lupus nephritis and may reduce reliance on invasive kidney biopsies.
How similar studies have performed: Earlier small studies have suggested uEVs can reflect kidney injury, but the method remains exploratory and is not yet validated for routine clinical use.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kolding and 3 other locations
- Kolding Hospital — Kolding, Denmark (Not_yet_recruiting)
- Department of Nephrology — Odense, Denmark (Not_yet_recruiting)
- Department of Rheumatology — Odense, Denmark (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.