Plasma Exchange for Renal Vasculitis
Plasma Exchange for Renal Vasculitis
The purpose of this study is to test whether additional therapy with plasma exchange improves
 the chances of kidney recovery in severe kidney vasculitis.
Primary systemic vasculitis associated with autoantibodies to neutrophil cytoplasmic antigens
 (ANCA), is the most frequent cause of rapidly progressive glomerulonephritis. Renal failure
 at presentation often progresses to end stage renal disease despite immunosuppressive
 therapy. We investigated whether the addition of plasma exchange was more effective than
 intravenous (IV) methyl prednisolone in the achievement of renal recovery for ANCA associated
 systemic vasculitis presenting with a serum creatinine above 500umol/l (5.8mg/dl).

 137 patients with a new diagnosis of ANCA associated systemic vasculitis, serum creatinine
 above 500umol/l (5.8mg/dl) and a renal biopsy demonstrating a focal, necrotizing
 glomerulonephritis were randomized to receive seven plasma exchanges or IV methyl
 prednisolone 1000mg/day for three days. Both groups were treated with cyclophosphamide and
 oral prednisolone. The primary end-point was dialysis independence with a serum creatinine
 below 500umol/l (5.8mg/dl) at three months. Secondary end-points included renal and patient
 survival at 12 months and severe adverse event rates.
Inclusion Criteria:

 -  Diagnosis of Wegener's granulomatosis or microscopic polyangiitis, using criteria
 adapted by EUVAS from the disease definitions of the Chapel Hill consensus conference

 -  Biopsy proven, pauci-immune, necrotising and/or crescentic glomerulonephritis, in the
 absence of other defined glomerulopathy

 -  Severe renal impairment defined by: (i) oliguria (<400ml/24hr), or (ii) intention to
 commence dialysis within 48 hours of admission, and (iii) creatinine >500umol/l
 (5.8mg/dl).

 Exclusion Criteria:

 -  Age under 18 or over 80 years

 -  Inadequate contraception in women of child-bearing age

 -  Pregnancy

 -  Previous malignancy

 -  Hepatitis B antigenaemia, anti-hepatitis C virus or anti-human immunodeficiency virus
 antibody

 -  Diagnosis of Churg-Strauss syndrome, Henoch-Schönlein purpura, rheumatoid vasculitis,
 mixed essential cryoglobulinaemia or systemic lupus erythematosus

 -  Circulating anti-GBM antibodies or linear IgG staining of the GBM on renal biopsy

 -  Life-threatening non-renal manifestations of vasculitis, including alveolar hemorrhage
 requiring mechanical ventilation within 24 hours of admission

 -  On dialysis for > two weeks prior to entry

 -  Creatinine > 200umol/l (2.3mg/dl) one year or more before entry

 -  A second clearly defined cause of renal failure

 -  Previous episode of biopsy-proven necrotising and/or crescentic glomerulonephritis

 -  > two weeks treatment with cyclophosphamide or azathioprine

 -  > 500mg IV methyl prednisolone

 -  Plasma exchange within the preceding year

 -  > three months treatment with oral prednisolone

 -  Allergy to study medications.