Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles

Launched by KOLDING SYGEHUS · Oct 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor lupus nephritis, a serious kidney condition that can occur in people with systemic lupus erythematosus (SLE). Researchers want to see if they can use tiny particles found in urine, called urinary extracellular vesicles (uEVs), as a non-invasive method to detect kidney problems in patients with lupus. Currently, doctors often rely on a kidney biopsy, which is an invasive procedure, to understand the condition. This study aims to find out if uEVs can be a safer and easier alternative.

To participate in this trial, you need to be over 18 years old and have a confirmed diagnosis of SLE. There are two main groups eligible: one group has kidney involvement and will be referred for a biopsy, while the other consists of SLE patients without kidney issues. Healthy individuals without any known kidney problems may also join the study. Participants can expect to provide urine samples for analysis and help researchers learn more about how to monitor kidney health in lupus patients. This research is important as it could lead to better, less invasive ways to manage lupus nephritis in the future.

Gender

ALL

Eligibility criteria

• • 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