Monitoring and Detecting Lupus Nephritis Through Urinary Extracellular Vesicles in Urine

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• \> 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

Locations
Other Locations
Denmark
Kolding Hospital
NOT_YET_RECRUITING
Kolding
Department of Nephrology
NOT_YET_RECRUITING
Odense
Department of Rheumatology
RECRUITING
Odense
Univesity of Southern Denmark
NOT_YET_RECRUITING
Odense
Contact Information
Primary
Rikke Z Langkilde, MD, phd
rikke.zachar.langkilde@rsyd.dk
4530281347
Backup
Anne D Thuesen, MD, phd, clinical lector
anne.daugaard.thuesen2@rsyd.dk
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2030-05-01
Participants
Target number of participants: 40
Treatments
Systemic lupus erythomatosus with lupus nephritis
SLE patients with kidney involvement
Systemic lupus erythomatosus without lupus nephritis
SLE patients, fulfilling the 2019 EULAR/ACR classification criteria with no sign of kidney disease
Healthy controls
Healthy controls
Biopsy controls
A biopsy control group with no predictive complement activation referred to biopsy
Sponsors
Leads: Kolding Sygehus
Collaborators: University of Southern Denmark, Odense University Hospital

This content was sourced from clinicaltrials.gov