Urinary T Lymphocytes Predict Renal Flares in Patients With Inactive ANCA-associated Glomerulonephritis
- Conditions
- Glomerulonephritis Acute
- Interventions
- Diagnostic Test: Analysis of urine samples with flow cytometry
- Registration Number
- NCT04428398
- Lead Sponsor
- Charite University, Berlin, Germany
- 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, 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No renal involvement Analysis of urine samples with flow cytometry Patients with ANCA-vasculitis and no ANCA-associated renal involvement in disease history Renal remission Analysis of urine samples with flow cytometry Patient with ANCA-vasculitis in renal remission
- Primary Outcome Measures
Name Time Method Prediction of renal relapse after six months depending initial CD4+ count 6 months * relapse defined as Birmingham Vasculitis Activity Score (BVAS) \> 1 + at least one renal element or
* intensified treatment regime (Prednisolon equivalent \> 20 mg/d or novel induction treatment with Rituximab or Cyclophosphamide)
- Secondary Outcome Measures
Name Time Method Prediction of renal relapse after 12 months depending initial CD8+ count 12 months Prediction of renal relapse after 12 months depending initial CD4+/CD8+ subsets 12 months Subsets: T effector memory cells (CD45RO+/CCR7-)
Prediction of renal relapse after six months depending initial CD4+/CD8+ subsets 6 months Subsets: T effector memory cells (CD45RO+/CCR7-)
Prediction of renal relapse after six months depending initial CD8+ count 6 months Prediction of renal relapse after 12 months depending initial CD4+ count 12 months
Trial Locations
- Locations (2)
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Helios Klinikum Berlin-Buch
🇩🇪Berlin, Germany