ANCA associated vasculitis Circulatory System Other disorders of arteries and arterioles
Conditions
Interventions
Plasma exchange versus high dose intravenous methyl prednisolone
Sponsors
Addenbrookes Hospital NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. New diagnosis of Wegener granulomatosis (WG), micropolyarteritis (MP) or its renal-limited variant, in accordance with the Chapel Hill Consensus criteria, with active vasculitis, as indicated by the presence of active necrotising glomerulonephritis on renal biopsy 2. Anti-neutrophilic cytoplasmic antibodies (ANCA) positivity: either a typical cytoplasmic-ANCA pattern by immunofluorescence test (IIF), and/or positivity in the proteinase-3 enzyme-linked immunosorbent assay (Pr3 ELISA), or positivity in the myeloperoxidase (MPO) ELISA, with or without perinuclear-ANCA (ANCA result will be confirmed by a nominated reference laboratory) 3. Biopsy-proven necrotising and/or crescentic glomerulonephritis, in the absence of another defined glomerulopathy, with severe renal impairment as defined by either: 3.1. Oliguria (less than 400 ml/24 hr) or 3.2. Intention to commence dialysis within 48 hours of admission
Exclusion criteria
Exclusion criteria: 1. Aged less than 18 or over 80 2. Inadequate contraception in women of child-bearing age 3. Pregnancy 4. Usually exclude patients with previous malignancy (unless agreed with trial coordinators) 5. Hepatitis B antigenaemia or detectable anti-hepatitis C virus antibody 6. Known anti-human immunodeficiency virus (anti-HIV) (HIV testing is not a requirement for this trial) 7. Diagnosis of Churg-Strauss syndrome, Henoch-Schonlein purpura, rheumatoid vasculitis, mixed essential cryoglobulinaemia, systemic lupus erythematosus, or the presence of circulating anti-glomerular basement membrane (anti-GBM) antibodies and linear gamma G immunoglobulin (IgG) staining of the GBM on renal biopsy, with intent to treat as anti-GBM mediated nephritis 8. Life-threatening non-renal manifestations of vasculitis, including alveolar haemorrhage requiring mechanical ventilation within 24 hours of admission 9. On dialysis for more than two weeks prior to referral 10. Significant baseline renal impairment: creatinine greater than 200 mmol/l one year or more before presentation 11. A second clearly defined cause of renal failure (e.g. urinary tract obstruction; not acute tubular necrosis [ATN]) 12. Previous episode of biopsy-proven necrotising and/or crescentic glomerulonephritis 13. Intravenous methylprednisolone (IVMeP), plasma exchange (PE) or pulsed intravenous cyclophosphamide within the preceding year 14. More than two weeks treatment with oral cyclophosphamide (Cyc) or azathioprine (Aza) 15. More than three months treatment with oral corticosteroids (OCS) 16. Allergy to study medications (excluding prophylactic agents) 17. Previous IVMeP therapy, which exceeds a single dose of 500 mg prior to referral to the participating centre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal recovery at three months | — |
Secondary
| Measure | Time frame |
|---|---|
| End stage renal disease at one year, severe adverse events | — |
Countries
United Kingdom
Outcome results
None listed