Status:
TERMINATED
Plasma Exchange for Renal Vasculitis
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
University Hospital Birmingham
Imperial College London
Conditions:
Wegener's Granulomatosis
Microscopic Polyangiitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
Primary systemic vasculitis associated with autoantibodies to neutrophil cytoplasmic antigens (ANCA), is the most frequent cause of rapidly progressive glomerulonephritis. Renal failure at presentatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01408836
Start Date
March 1 1995
End Date
December 1 2003
Last Update
August 3 2011
Active Locations (1)
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1
Addenbrooke's Hospital
Cambridge, Cambridge, United Kingdom, CB22QQ