Plasma Exchange for Renal Vasculitis

• Status: Terminated
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test whether additional therapy with plasma exchange improves the chances of kidney recovery in severe kidney vasculitis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: Fundacio Clinic; Fundacio Clinic Barcelona; Helsinki University; Imperial College London; London North West Healthcare NHS Trust; Lund University Hospital; University Hospital Birmingham; University Hospitals, Leicester; University Medical Center Groningen; University of Helsinki
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.