Scope change in vasculitis: the role of monocytes and macrophages in ANCA-associated glomerulonephritis

Scope change in vasculitis: the role of monocytes and macrophages in ANCA-associated glomerulonephritis - MOMA study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55167

Enrollment

103

Registered

2020-09-11

Start date

2020-11-09

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ANCA vasculitis with renal involvement ANCA-associated glomerulonephritis

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Secundary study parameters are T-cell receptor repertoires of migrated T-cells, HLA-DPB1*04:01 status in AGN patients, quality of life (SF-36, patient reported outcome measure, disease specific: AAV-PRO), fatigue levels (SF-36, AAV-PRO)	—

Countries

Netherlands

Outcome results