Plasma Exchange and Glucocorticoid in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomised Controlled Trial.

Phase 1

• Conditions: ANCA associated vasculitis; MedDRA version: 18.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2009-013220-24-CZ
• 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: 2010-03-19
• Study Completion: 2017-07-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

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

Inclusion Criteria

1) New or previous diagnosis of ANCA associated vasculitis
2) Positive test, at any point in the subject´s disease course, by ELISA, for proteinase 3-ANCA or myeloperoxidase - ANCA
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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

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 (In the Czech Republic age < 18)
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 on condition that, in the opinion of the investigator, precludes the use of cyclophosphamide/rituximab, glucocorticoids, or plasma exchange or absolutely mandates the use of plasma exchange.
8) Plasma Exchange in 3 months prior to randomization.

Study & Design

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