Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomised Controlled Trial - PEXIVAS (Version 1)
- Conditions
- ANCA associated vasculitisMedDRA version: 12 Level: LLT Classification code 10050894 Term: Anti-neutrophil cytoplasmic antibody positive vasculitis
- Registration Number
- EUCTR2009-013220-24-GB
- Lead Sponsor
- Addenbrooke's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 704
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? yes
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
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method