Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles
Recruiting now
Conditions studied: Systemic Lupus Erythematosus Nephritis
In brief
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.
Key facts
- Study ID
- NCT06642402
- Run by
- Kolding Sygehus
- People needed
- 40
- Starts
- 2024-11-15
- Expected to finish
- 2030-05-01
- Last updated by the study team
- 2025-09-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- > 18 years old
- Fulfilling the 2019 EULAR/ACR classification criteria
- Positive autoantibodies, medical history and obejctive examination compatible with SLE
- Referred to kidney biopsy
You may not qualify if…
- 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
Where it is running
- Department of Rheumatology — Odense, Denmark (enrolling)
- Kolding Hospital — Kolding, Denmark
- Department of Nephrology — Odense, Denmark
- Univesity of Southern Denmark — Odense, Denmark
Full record on ClinicalTrials.gov
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