NCT06642402Recruiting
Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles
Monitoring and Detecting Lupus Nephritis Through Urinary Extracellular Vesicles in Urine
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 11 Oct 2024
- Start date
- 15 Nov 2024
- Primary completion date
- 1 May 2029
- Lead sponsor
- Kolding Sygehus
- Diseases
- Lupus (SLE)
- NCT number
- NCT06642402
What you commit to
- Study type: Observational
- Planned participants: 40
- From 15 Nov 2024 to the primary completion date, 1 May 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Significant comorbidity, which is considered to potentially impact the outcome
- SLE patients with no sign of kidney disease
Lab values
- Urine albumin-creatinine ratio \> 100 mg/g or proteinuria \> 100 mg/day
Other
- Lack of ability or willingness to provide informed consent
- 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
- 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
Who the study is looking for
- \> 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
Criteria the registry did not label
- SLE patients with kidney involvement
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kolding Hospital Coordinator of this site? Confirm its status | Kolding | Denmark | Not yet recruiting |
| Department of Nephrology Coordinator of this site? Confirm its status | Odense | Denmark | Not yet recruiting |
| Univesity of Southern Denmark Coordinator of this site? Confirm its status | Odense | Denmark | Not yet recruiting |
| Department of Rheumatology Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.