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

Completed

• Conditions: ANCA vasculitis with renal involvement; ANCA-associated glomerulonephritis; 10003816; 10038430; 10047066

• Registration Number: NL-OMON55167
• Lead Sponsor: Academisch Medisch Centrum

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

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 invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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