Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles
Recruiting · NCT06642402 · Observational (researchers observe without assigning treatment) · Lead sponsor: Kolding Sygehus
View the official record on ClinicalTrials.gov →Interventions studied
Autoimmunity in plasmaKidney biopsyUrinary extracellular vesicle testing
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
4 locations listed.
- Kolding Hospital - Kolding, Denmark
- Department of Nephrology - Odense, Denmark
- Department of Rheumatology - Odense, Denmark
- Univesity of Southern Denmark - Odense, Denmark