The role of monocytes and macrophages in the development of ANCA vasculitis in the kidneys

Not Applicable

Completed

• Conditions: <p>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis</p>; ANCA vasculitis; 10003816

• Registration Number: NL-OMON29001
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 103

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet following general and group-specific criteria: General 1. Age: 18 years and older Group-specific Patients with ANCA-associated glomerulonephritis (AGN) 1. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) 2. Renal involvement attributable to vasculitis 3. History of PR3/MPO positivity as determined by ELISA in the context of routine clinical care. Hemodialysis controls 1. End stage kidney failure (ESRD) requiring hemodialysis Active infection controls 1. Clinical diagnosis: pneumonia (CURB-65 score 2-5, imaging: X-thorax or CT-thorax showing infiltrates) or complicated urine tract infection 2. Admitted to the hospital <48h Nephrectomy controls 1. Patients who undergo a (partial) nephrectomy for treatment of a renal cell carcinoma, who give consent for the use of surplus kidney tissue for research purposes Patients with (suspected) ANCA vasculitis with pulmonary involvement (API) 1. Suspected or diagnosed with ANCA-associated vasculitis 2. (Suspected) pulmonary involvement attributable to vasculitis 3. Patients who undergo a bronchoalveolar lavage (BAL) for diagnostic purposes SLE patients with renal involvement 1. SLE diagnosis according to the 2019 EULAR/ACR Classification Criteria18 2. Renal involvement attributable to SLE 3. History of ANA positivity

Exclusion Criteria

Patients with ANCA-associated glomerulonephritis (AGN) and Patients with (suspected) ANCA vasculitis with pulmonary involvement 1. A history of drug-induced ANCA-associated vasculitis 2. Active infection as shown by microbiological analysis 3. A history of any other auto-immune disease Healthy controls and hemodialysis controls 1. Active infection as shown by microbiological analysis 2. A history of any auto-immune disease 3. Use of immunosuppressive medication Infection controls 1. Other infection than pneumonia/urine tract infection 2. A history of any auto-immune disease 3. Use of immunosuppressive medication SLE patients 1. A history of drug-induced SLE 2. Active infection as shown by microbiological analysis

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are mRNA and protein expression levels of monocyte-derived macrophages in vitro and macrophages in situ in renal biopsies, and activation and migration of T-cells which are co-cultured with activated macrophages.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To relate HLA-DPB1*04:01 genotype, quality of life and fatigue measurements and clinical parameters (disease activity (BVAS, VDI), immunosuppressive medication) to macrophage phenotype (in vitro and in situ) and Tcell activation and migration.</p><br>