Urinary T Lymphocytes Predict Renal Flares in Patients With Inactive ANCA-associated Glomerulonephritis

Charite University, Berlin, Germany100 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Glomerulonephritis Acute

Interventions

Analysis of urine samples with flow cytometryDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (2)

Charité - Universitätsmedizin Berlin

Berlin, Germany

Helios Klinikum Berlin-Buch

Berlin, Germany

Outcomes

Primary Outcomes

Prediction of renal relapse after six months depending initial CD4+ count

* 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)

Time frame: 6 months

Secondary Outcomes

Prediction of renal relapse after six months depending initial CD8+ count

Time frame: 6 months

Prediction of renal relapse after six months depending initial CD4+/CD8+ subsets

Subsets: T effector memory cells (CD45RO+/CCR7-)

Time frame: 6 months

Prediction of renal relapse after 12 months depending initial CD4+ count

Time frame: 12 months

Prediction of renal relapse after 12 months depending initial CD8+ count

Time frame: 12 months

Prediction of renal relapse after 12 months depending initial CD4+/CD8+ subsets

Subsets: T effector memory cells (CD45RO+/CCR7-)

Time frame: 12 months

Data from ClinicalTrials.gov

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