Plasma EXchange and glucocorticoids In anti-neutrophil cytoplasm antibody associated systemic VASculitis

Principal Investigator: Dr Chen Au Peh
Project Officer: Andrea Valks (AKTN)
Trial Number: EUDRACT 2009-013220-24

Population: Patients with ANCA-associated vasculitis, as shown by either severe renal impairment or severe lung haemorrhage.

Intervention: PLEX vs no PLEX in combination with standard dose vs reduced dose glucocorticoids
Follow-up: 1-7 years
Primary outcome: Composite of all-cause mortality or end-stage kidney disease
Status: Trial completed
Recruitment end date: 30 November 2016
Follow-up end date: 31 December 2017
Recruitment: 704/700

Trial Summary

Vasculitis is an inflammation of the small blood vessels in the body leading to a restriction of blood supply to organs and tissues. When the kidneys or lungs are affected, “plasma exchange” can be used as an effective treatment option. It quickly removes an antibody called ANCA (as well as other harmful substances) so that the disease can be controlled and kidneys and/or lungs can recover. The treatment method of plasma exchange combined with drugs (steroids and cyclophosphamide), is effective at controlling the disease but has toxic side effects, particularly infections. It is important to use the correct dose of these drugs in order to balance their benefit with their side effects but unfortunately it is unknown what the correct dose should be.

The PEXIVAS Trial is open to patients with ANCA Vasculitis where the kidneys and/or lungs are affected. They are randomised to either receive plasma exchange or no plasma exchange and a standard dose of steroids or a reduced dose of steroids. The study runs for seven years and the results will reveal the ideal dosage for controlling Vasculitis and in doing so, greatly improve the quality of life of those with Vasculitis.