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Clinical Trial Summary

Urinary CD4+ and CD8+ T lymphocytes may predict renal flares in patients with inactive ANCA-associated vasculitis and thus serve as early non-invasive biomarkers. Urine samples of patients with inactive renal ANCA-vasculitis will be analysed by flow cytometry and compared to clinical outcome after 6 months.


Clinical Trial Description

Data of previous studies have shown that counts of urinary T lymphocyte subsets correlate with disease activity in several immunological renal diseases, e.g. ANCA-associated glomerulonephritis. Thus, study authors hypothesise that CD4+, respectively CD8+, T effector memory lymphocytes found in urine samples of patients with inactive ANCA-vasculitis predict subsequent renal flares. Therefore, quantification of these cellular subsets might reliably predict relapse of ANCA associated glomerulonephritis at an early stage. In a prospective experimental study urine of patients with ANCA-vasculitis and no renal involvement or patients in renal remission will be analysed by flow cytometry. After 6 months of observation, clinical outcome and potential renal relapse will be determined and correlated to initial T lymphocyte count. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04428398
Study type Observational
Source Charite University, Berlin, Germany
Contact
Status Completed
Phase
Start date May 1, 2020
Completion date September 1, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04320667 - Urinary T Cell Biomarker for Prediction in ANCA Glomerulonephritis