Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles

September 2, 2025 updated by: Kolding Sygehus

Monitoring and Detecting Lupus Nephritis Through Urinary Extracellular Vesicles in Urine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction: 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 based on its histopathological features. The classification helps in determining the severity and appropriate treatment strategies for the condition and to rule out other conditions that may mimic the clinical picture of LN. The classification system most commonly used is the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification, which divides lupus nephritis into six classes: I) Minimal Change, II) Mesangial Proliferative LN, III) Focal Proliferative LN, IV) Diffus proliferative LN, V) Membranous LN, VI) Advanced Sclerosing LN. The classification requires invasive kidney biopsies, which are hardly accessible and associated with potential complications and patient discomfort. Furthermore the kidney biopsy only represent a small part of the kidney. Recent research has suggested urinary extracellular vesicles (uEVs) as potential non-invasive biomarkers for kidney diseases, including LN. uEVS are small nano-sized extracellular vesicles of endosomal origin, which are secreted into the urine through fusion of multivesicular bodies with the plasma membrane. Thus, they could represent a promising liquid biopsy that reflects the pattern and/or severity of renal injury.

Hypothesis: The primary objective of this prospective study is to investigate the utility of urinary exosomes as non-invasive biomarkers for monitoring the activity and progression of lupus nephritis.

Methods: SLE patients, fulfilling the 2019 EULAR/ACR classification criteria, referred to kidney biopsy, will be recruited from Department of Rheumatology and Department of Nephrology at Odense University Hospital. 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. Activity of SLE at the time of biopsy will be evaluated using SLE disease activity index 2000 (SLEDAI-2K). SLE damage will be evaluated in accordance with the SLICC damage index. Spot-urine samples will be collected, added protease-inhibitors and frozen at -80 degree. UEVs will be isolated using polyethylene glycol (PEG) precipitation, the concentration of uEV will be determined and protein accessed using western blotting and/or PCR. Glomerular specific uEVs will be isolated and previous developed tests will be applied to detect the membrane attack complex (MAC)/C5b-9 complex. uEVs from plasma/serum will be isolated to test for correlation with uEVs. Kidney biopsies will be histological analyzed at Department of Pathology by experienced nephropathologists according to existing clinical guidelines. Differences in uEV cargo between SLE patients with and without lupus nephritis will be analyzed using appropriate statistical tests. Correlations between uEV biomarkers, histological differences on the kidney biopsy and disease activity will be evaluated using Pearson's correlation analysis.

Perspective: This prospective study aims to establish urinary extracellular vesicles as potential non-invasive biomarkers for monitoring lupus nephritis in SLE patients. The findings from this research may lead to the development of more efficient and patient-friendly approaches for LN management, enabling timely interventions and improved renal outcomes in SLE patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Kolding, Denmark
        • Not yet recruiting
        • Kolding Hospital
        • Contact:
      • Odense, Denmark, 5000
        • Not yet recruiting
        • Department of Nephrology
        • Contact:
          • michael Aarup, MD, consultant
      • Odense, Denmark, 5000
      • Odense, Denmark, 5230
        • Not yet recruiting
        • Univesity of Southern Denmark
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

SLE patients with kidney involvement

Inclusion criteria:

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

Exclusion criteria:

  • 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

Inclusion criteria:

  • > 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

Exclusion criteria:

  • Lack of ability or willingness to provide informed consent
  • Significant comorbidity, which is considered to potentially impact the outcome

Healthy controls:

Inclusion criteria:

  • > 18 years old
  • No known kidney disease

Exclusion criteria:

  • 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:

Inclusion criteria:

  • > 18 years old
  • Negative autoantibiodies and immunoglobulines
  • Referred to kidney biopsy

Exclusion criteria:

  • Lack of ability or willingness to provide informed consent
  • Significant comorbidity, which is considered to potentially impact the outcome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy controls
Diagnostic test: Urinary extracellular vesicle testing
Urinary extracellular vesicles will be isolated and tested for complement activation and other markers of kidney disease
Systemic lupus erythomatosus with lupus nephritis
SLE patients with kidney involvement
Diagnostic test: Kidney biopsy
Patient refered to kidney biopsy independent of the presented study
Other Names:
  • No expected complement activation
Diagnostic test: Urinary extracellular vesicle testing
Urinary extracellular vesicles will be isolated and tested for complement activation and other markers of kidney disease
Diagnostic test: Autoimmunity in plasma
Expected autoimmunity in plasma isolated from blood samples
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 testing
Urinary extracellular vesicles will be isolated and tested for complement activation and other markers of kidney disease
Diagnostic test: Autoimmunity in plasma
Expected autoimmunity in plasma isolated from blood samples
Biopsy controls
A biopsy control group with no predictive complement activation referred to biopsy
Diagnostic test: Kidney biopsy
Patient refered to kidney biopsy independent of the presented study
Other Names:
  • No expected complement activation
Diagnostic test: Urinary extracellular vesicle testing
Urinary extracellular vesicles will be isolated and tested for complement activation and other markers of kidney disease

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation between kidney biopsy and urinay extracellular vesicles
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.
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
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between urinary extracellular vesicles and extracellular vesicles from plasma
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.
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kolding Sygehus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Odense University Hospital
University of Southern Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Anne F Christensen, Chief of Medicine, MD, phd, Sygehus Lillebaelt, Kolding Hospitl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SLELNuEV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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