Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis: an international randomized controlled trial - PEXIVAS

Phase 1

• Conditions: Anti-neutrophil Cytoplasm Antibody (ANCA) Associated Vasculitis (which comprises Wegener's Granulomatosisand Microscopic Polyangiits); MedDRA version: 12.1Level: LLTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitis

• Registration Number: EUCTR2009-013220-24-DK
• Lead Sponsor: Cambridge University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-03
• Study Completion: 2017-07-31
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 704

Inclusion Criteria

1) New or previous diagnosis of ANCA associated vasculitis
2) Has either PR3 or MPO positive antibody(ANCA) binding by ELISA or equivalent
3) Has a severe manifestation of vasculitis as defined by either a) renal vasculitis resulting in an estimated
glomerular filtration rate below 50 ml/min; or b) lung haemorrhage
4) Provision of informed consent by patient or a surrogate decision maker
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Presence of concomitant anti-glomerular basement membrane disease or another vasculitic disease
2) Requirement for dialysis for >21 days in the period immediately preceeding enrollment
3) Age <15 years
4) Pregnancy
5) Inability or unwillingness to comply with birth control/abstinence
6) Treatment for vasculitis with cyclophosphamide and/or glucocorticoids for >14 days prior to randomisation or
rituximab >28 days prior to randomisation
7) A comorbidity that, in the opinion of the investigator, mandates the use plasma exchange or precludes the use
of reduced dose glucocorticoids

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified