Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles
Monitoring and Detecting Lupus Nephritis Through Urinary Extracellular Vesicles in Urine
Kolding Sygehus
40 participants
Nov 15, 2024
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria15
- SLE patients with kidney involvement
- > 18 years old
- Fulfilling the 2019 EULAR/ACR classification criteria
- Positive autoantibodies, medical history and obejctive examination compatible with SLE
- Referred to kidney biopsy
- > 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
- > 18 years old
- No known kidney disease
- > 18 years old
- Negative autoantibiodies and immunoglobulines
- Referred to kidney biopsy
Exclusion Criteria13
- 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
- Lack of ability or willingness to provide informed consent
- Significant comorbidity, which is considered to potentially impact the outcome
- Healthy controls:
- 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:
- Lack of ability or willingness to provide informed consent
- Significant comorbidity, which is considered to potentially impact the outcome
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Interventions
Patient refered to kidney biopsy independent of the presented study
Urinary extracellular vesicles will be isolated and tested for complement activation and other markers of kidney disease
Expected autoimmunity in plasma isolated from blood samples
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06642402