Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04428398
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2020-06-09
Brief Title:
Urinary T Lymphocytes Predict Renal Flares in Patients With Inactive ANCA-associated Glomerulonephritis
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Urinary T Lymphocytes Predict Renal Flares in Patients With Inactive Anti-neutrophil Cytoplasmic Antibody ANCA Associated Glomerulonephritis
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRE-FLARED
Brief 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
Detailed Description:
Data of previous studies have shown that counts of urinary T lymphocyte subsets correlate with disease activity in several immunological renal diseases eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None