Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKolding Sygehus
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
> 18 years old
Fulfilling the 2019 EULAR/ACR classification criteria
Positive autoantibodies, medical history and obejctive examination compatible with SLE
Referred to kidney biopsy
Disqualifiers
Lack of ability or willingness to provide informed consent
Significant comorbidity, which is considered to potentially impact the outcome
> 18 years old
Fulfilling the 2019 EULAR/ACR classification criteria
Trial population
Patients known with SLE with and without kidney involvement, a biopsy control and a group of healthy controls.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Kidney biopsy
Diagnostic testPatient refered to kidney biopsy independent of the presented study
Urinary extracellular vesicle testing
Diagnostic testUrinary extracellular vesicles will be isolated and tested for complement activation and other markers of kidney disease
Autoimmunity in plasma
Diagnostic testExpected autoimmunity in plasma isolated from blood samples
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Systemic lupus erythomatosus with lupus nephritis3 interventions
Group B: Systemic lupus erythomatosus without lupus nephritis2 interventions
Group C: Healthy controls1 intervention
Group D: Biopsy controls2 interventions
Trial outcomes
Primary outcomes
1
Correlation between kidney biopsy and urinay extracellular vesicles
The primary outcome is to investigate the correlation between histological findings from kidney biopsy and urinary extracelluar vesicles, with the aim of assessing whether there is concordance between the two methods in relation to disease severity and classification.
Time frame
Urinary extracellular vesicles will be isolated from urine collected at the day of kidney biopsy/baseline. Analysis will be performed when all samples are collected. Estimated after 5 years.2
Complement activation in urinary extracellular vesicles
Urinary extracellular vesicles will be isolated. Complement activation will be detected using an in-house ELISA assay
Time frame
Measured on urinary extracellular vesicles obtained at the day of biopsy/baseline. Analysis will be performed when all samples are collected, estimated after 5 years.Secondary outcomes
1
Correlation between urinary extracellular vesicles and extracellular vesicles from plasma
A seconday outcome is to invesigate the correlation between urinary extracellular vesicles and extracellular vesicles from plasma, to see if the same results could be obtained in plasma samples
Time frame
Blood- og and urine samples will be collected at the day of kidney biopsy/baseline. Analysis will be performed when all samples are collecting, estimated after 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kolding Sygehus
Lead sponsor
University of Southern Denmark
Collaborator
Odense University Hospital
Collaborator
Source ClinicalTrials.gov