Fibrocytes in glomerulonephritis(FIG) study
Research type
Research Study
Full title
The FIG study: Fibrocytes in glomerulonephritis. A substudy of the PEXIVAS trial.
IRAS ID
123977
Contact name
Lorraine Harper
Contact email
Sponsor organisation
University of Birmingham
Research summary
This study is a sub-study of an international randomised controlled trial referred to as PEXIVAS(Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis). PEXIVAS is currently in the recruitment phase and has been subjected to REC review. The FIG study is a prospective observational study focusing on patients recruited through PEXIVAS.
Anti-neutrophil cytoplasm antibody associated vasculitis (AAV) describes a group of diseases that result in rapid kidney and lung failure due to inflammation. This disorder is caused by a poorly defined autoimmune process, where a patients own immune system attacks itself. Even with treatment many patients may be left with longstanding disabling kidney tissue damage and scarring. Untreated AAV is often fatal.
To date, the mechanisms of inflammation and scarring in human kidney disease associated with AAV remain unclear but are thought to be associated with the appearance of fibroblasts, cells that are involved in wound healing. The origins of these cells is unclear but they may either develop from existing kidney cells, or be recruited from the blood in the form of circulating fibroblast progenitor cells called ‘fibrocytes’.
This is an observational study to help us understand what cells are drawn to the kidney in patients with an acute deterioration in renal function patients due to AAV. We will take blood and use an assay called ‘flow cytometry’ to count the number of fibrocytes in the blood. Laboratory observations will be correlated against patient clinical data.
This international multi-centre study will recruit 150 subjects with active, newly diagnosed AAV. Patients are already under recruitment through McMaster University, Canada where this study was first concieved.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
13/WM/0439
Date of REC Opinion
11 Nov 2013
REC opinion
Favourable Opinion