NCT06642402

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
48mo left

Started Nov 2024

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Nov 2024May 2030

First Submitted

Initial submission to the registry

October 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

October 11, 2024

Last Update Submit

September 2, 2025

Conditions

Systemic Lupus Erythematosus Nephritis

Keywords

Systemic Lupus Erythoematosus nephritisLupus nephritiscomplement activationkidney biopsy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

  • Complement activation in urinary extracellular vesicles

    Urinary extracellular vesicles will be isolated. Complement activation will be detected using an in-house ELISA assay

    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

    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.

Study Arms (4)

Systemic lupus erythomatosus with lupus nephritis

SLE patients with kidney involvement

Diagnostic Test: Kidney biopsyDiagnostic Test: Urinary extracellular vesicle testingDiagnostic Test: Autoimmunity in plasma

Systemic lupus erythomatosus without lupus nephritis

SLE patients, fulfilling the 2019 EULAR/ACR classification criteria with no sign of kidney disease

Diagnostic Test: Urinary extracellular vesicle testingDiagnostic Test: Autoimmunity in plasma

Healthy controls

Healthy controls

Diagnostic Test: Urinary extracellular vesicle testing

Biopsy controls

A biopsy control group with no predictive complement activation referred to biopsy

Diagnostic Test: Kidney biopsyDiagnostic Test: Urinary extracellular vesicle testing

Interventions

Kidney biopsyDIAGNOSTIC_TEST

Patient refered to kidney biopsy independent of the presented study

Also known as: No expected complement activation
Biopsy controlsSystemic lupus erythomatosus with lupus nephritis
Urinary extracellular vesicle testingDIAGNOSTIC_TEST

Urinary extracellular vesicles will be isolated and tested for complement activation and other markers of kidney disease

Biopsy controlsHealthy controlsSystemic lupus erythomatosus with lupus nephritisSystemic lupus erythomatosus without lupus nephritis
Autoimmunity in plasmaDIAGNOSTIC_TEST

Expected autoimmunity in plasma isolated from blood samples

Systemic lupus erythomatosus with lupus nephritisSystemic lupus erythomatosus without lupus nephritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients known with SLE with and without kidney involvement, a biopsy control and a group of healthy controls.

You may qualify if:

  • \> 18 years old
  • Fulfilling the 2019 EULAR/ACR classification criteria
  • Positive autoantibodies, medical history and obejctive examination compatible with SLE
  • Referred to kidney biopsy

You may not qualify if:

  • 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
  • \> 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
  • Lack of ability or willingness to provide informed consent
  • Significant comorbidity, which is considered to potentially impact the outcome
  • Healthy controls:
  • \> 18 years old
  • No known kidney disease
  • Lack of ability or willingness to provide informed consent
  • Urine albumin-creatinine ratio \> 100 mg/g or proteinuria \> 100 mg/day
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kolding Hospital

Kolding, Denmark

NOT YET RECRUITING

Department of Nephrology

Odense, 5000, Denmark

NOT YET RECRUITING

Department of Rheumatology

Odense, 5000, Denmark

RECRUITING

Univesity of Southern Denmark

Odense, 5230, Denmark

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Detailed demographic and clinical data including age, sex, ethnicity, medicine, duration of SLE activity, SLE damage and laboratory results will be collected from each patient. Blood samples will be collected and tested for immun markers of lupus nephritis. Urine samples willl be collected to detect kidney function and to isolate urinary extracellular vesicles. Kidney biopsies will be histological analyzed at department of Pathology by experienced nephro-pathologists according to existing clinical guidelines.

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Autoimmunity

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunityImmune System Phenomena

Study Officials

  • Anne F Christensen, Chief of Medicine, MD, phd

    Sygehus Lillebaelt, Kolding Hospitl

    STUDY CHAIR

Central Study Contacts

Rikke Z Langkilde, MD, phd

CONTACT

4530281347rikke.zachar.langkilde@rsyd.dk

Anne D Thuesen, MD, phd, clinical lector

CONTACT

anne.daugaard.thuesen2@rsyd.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 15, 2024

Study Start

November 15, 2024

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2030

Last Updated

September 9, 2025

Record last verified: 2025-09

Locations

DK(4)