RecruitingNCT06642402

Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles

Monitoring and Detecting Lupus Nephritis Through Urinary Extracellular Vesicles in Urine


Sponsor

Kolding Sygehus

Enrollment

40 participants

Start Date

Nov 15, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria15

  • SLE patients with kidney involvement
  • > 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

Exclusion Criteria13

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

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Interventions

DIAGNOSTIC_TESTKidney biopsy

Patient refered to kidney biopsy independent of the presented study

DIAGNOSTIC_TESTUrinary extracellular vesicle testing

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

DIAGNOSTIC_TESTAutoimmunity in plasma

Expected autoimmunity in plasma isolated from blood samples


Locations(4)

Kolding Hospital

Kolding, Denmark

Department of Nephrology

Odense, Denmark

Department of Rheumatology

Odense, Denmark

Univesity of Southern Denmark

Odense, Denmark

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NCT06642402