Status:
COMPLETED
Urinary T Lymphocytes Predict Renal Flares in Patients With Inactive ANCA-associated Glomerulonephritis
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Glomerulonephritis Acute
Eligibility:
All Genders
18+ years
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 inacti...
Detailed 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, ...
Eligibility Criteria
Inclusion
- diagnosed ANCA-associated vasculitis (clinical diagnosis of granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions AND positive test for proteinase 3-ANCA or myeloperoxidase-ANCA)
- no currently active renal involvement (defined as BVAS = 0 with exception of hematuria or proteinuria as signs of renal scars)
- written and informed consent
Exclusion
- urinary tract infection
- active menstrual bleeding
- active renal involvement
- other active renal disease (e.g. diabetic nephropathy)
- Initially, we defined treatment with rituximab as exclusion criteria. However, upon closer examination, we recognized that this exclusion criterion was overly restrictive and may have inadvertently excluded eligible participants who met our other inclusion criteria. As a result of this reassessment, we have revised our exclusion criteria to no longer exclude individuals solely on the basis of receiving rituximab treatment.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04428398
Start Date
May 1 2020
End Date
September 1 2021
Last Update
November 14 2023
Active Locations (2)
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1
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
2
Helios Klinikum Berlin-Buch
Berlin, Germany, 13125