NCT04320797

Urinary T Cell Biomarker for Prediction in Lupus Nephritis

Phenotype of Urinary CD4+ T Cells as Biomarkers for Prediction of Outcome in Lupus Nephritis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 79 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Flow cytometry analysis of urine samples	Urine samples will be conserved and frozen upon arrival. All samples will be stained according to T cell and TEC (tubular epithelial cells) panel with fluorochromes. T cell panel: CD3, CD4, CD8, CCR7, CD45RO, CD28, CD279; TEC panel: vimentin, cytokeratine, CD10, CD13, CD227, CD326

Timeline

• Start date: 2019-07-30
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-03-25
• Last updated: 2022-03-09

Locations

2 sites across 2 countries: Germany, United Kingdom