Urinary T Cell Biomarker for Prediction in Lupus Nephritis

Charité University Medicine Berlin

Status: Unknown

Conditions: Lupus Nephritis

Treatments: Diagnostic Test: Flow cytometry analysis of urine samples

Study type: Observational

Funder types: Other

Identifiers

NCT04320797

SLEFLURINOCYTE

Details and patient eligibility

About

Urinary T-lymphocytes may be predictive for clinical outcome in patients with lupus nephritis. The investigators hypothesize that the amount of CD4+ effector/memory T-cells in urine at time of diagnosis predicts the outcome of patients with active lupus nephritis (LN) after 6 months of therapy. In a prospective, six-months follow-up study patients' urine will be analysed by flow cytometry every 60 days (+/- 10d). Treatment will be performed to the discretion of the treating clinician. After 6 months of treatment response will be determined as either complete response or partial response.

Enrollment: 79 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy proven lupus nephritis
• In absence of a biopsy a SLEDAI of at least 10 & at least two renal elements of the renal SLEDAI (rSLEDAI)
• Informed consent
• Diagnosis of SLE according to the American College of Rheumatology (ACR) criteria

Exclusion criteria

• Biopsy-proven non-SLE related disease
• Urinary tract infection
• Active menstrual bleeding
• Kidney transplantation during observation time

Trial design

79 participants in 2 patient groups

Active lupus nephritis

Description:

Patients with proliferative lupus nephritis (Class III and IV)

Treatment:

Diagnostic Test: Flow cytometry analysis of urine samples

Control

Description:

Patients with systemic lupus erythematodes without lupus nephritis or lupus nephritis I, II or VI

Treatment:

Diagnostic Test: Flow cytometry analysis of urine samples