Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06642402

Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles

Led by Kolding Sygehus · Updated on 2025-09-09

40

Participants Needed

4

Research Sites

284 weeks

Total Duration

On this page

Sponsors

K

Kolding Sygehus

Lead Sponsor

U

University of Southern Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

Lupus nephritis (LN) is a severe manifestation of systemic lupus erythematosus (SLE) that can lead to irreversible kidney damage if not detected and managed promptly. LN is classified and treated based on its histopathological features obtained by invasive kidney biopsy. Recent research has suggested urinary extracellular vesicles (uEVs) as potential non-invasive biomarkers. The primary objective of this prospective study is to investigate the utility of uEVs in LN.

CONDITIONS

Official Title

Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of systemic lupus erythematosus (SLE) based on 2019 EULAR/ACR criteria
  • Positive autoantibodies, medical history, and examination consistent with SLE
  • Referred to kidney biopsy (for lupus nephritis group)
  • Normal plasma creatinine and urine albumin/creatinine ratio below 100 mg/g (for SLE patients without kidney disease)
  • No known kidney disease (for healthy controls)
  • Negative autoantibodies and immunoglobulins and referred to kidney biopsy (for biopsy control group)
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent
  • Significant other medical conditions that could affect study outcomes
  • Urine albumin-creatinine ratio above 100 mg/g or proteinuria over 100 mg/day (for healthy controls)
  • Positive autoantibodies (for healthy controls)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Kolding Hospital

Kolding, Denmark

Not Yet Recruiting

2

Department of Nephrology

Odense, Denmark, 5000

Not Yet Recruiting

3

Department of Rheumatology

Odense, Denmark, 5000

Actively Recruiting

4

Univesity of Southern Denmark

Odense, Denmark, 5230

Not Yet Recruiting

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Research Team

R

Rikke Z Langkilde, MD, phd

CONTACT

A

Anne D Thuesen, MD, phd, clinical lector

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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