Status:
COMPLETED
Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Cambridge University Hospitals NHS Foundation Trust
University of Birmingham
Conditions:
Granulomatosis With Polyangiitis (Wegener's) (GPA)
Microscopic Polyangiitis (MPA)
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether plasma exchange as well as immunosuppressive therapy are effective in reducing death and end-stage renal disease (ESRD). The trial will also study whe...
Detailed Description
Granulomatosis with polyangiitis (Wegener's) (WG) and microscopic polyangiitis (MPA) are syndromes of primary systemic vasculitis associated with anti-neutrophil cytoplasm antibodies (ANCA). Together,...
Eligibility Criteria
Inclusion
- • New or previous clinical diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions
- AND
- • Positive test for proteinase 3-ANCA or myeloperoxidase-ANCA
- AND
- Severe vasculitis defined by at least one of the following:
- Renal involvement characterized by both of the following:
- Renal biopsy demonstrating focal necrotizing glomerulonephritis or active urine sediment characterized by glomerular haematuria or red cell casts and proteinuria
- AND
- eGFR \<50 ml/min/1.73 m2
- Pulmonary hemorrhage due to active vasculitis defined by:
- A compatible chest x-ray or CT scan (diffuse pulmonary infiltrates)
- AND
- The absence of an alternative explanation for all pulmonary infiltrates (e.g. volume overload or pulmonary infection)
- AND
- At least one of the following:
- Evidence of alveolar hemorrhage on bronchoscopic examination or increasingly bloody returns with bronchoalveolar lavage
- Observed hemoptysis
- Unexplained anemia (\<10 g/dL) or documented drop in hemoglobin \>1 g/dL)
- Increased diffusing capacity of carbon dioxide
- Provision of informed consent by patient or a surrogate decision maker
Exclusion
- A diagnosis of vasculitis other than granulomatosis with polyangiitis or microscopic polyangiitis
- Positive serum anti-glomerular basement membrane antibody test or renal biopsy demonstrating linear glomerular immunoglobulin deposition
- Receipt of dialysis for \>21 days immediately prior to randomization or prior renal transplant
- Age \<15 years
- Pregnancy at time of study entry
- Treatment with \>1 IV dose of cyclophosphamide and/or \>14 days of oral cyclophosphamide and/or \>14 days of prednisone/prednisolone (\>30 mg/day) and/or \>1 dose of rituximab within the 28 days immediately prior to randomization
- A comorbidity that, in the opinion of the investigator, precludes the use of cyclophosphamide, glucocorticoids, or plasma exchange or absolutely mandates the use of plasma exchange
- Plasma exchange in 3 months prior to randomization
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
704 Patients enrolled
Trial Details
Trial ID
NCT00987389
Start Date
May 1 2010
End Date
August 1 2017
Last Update
May 26 2020
Active Locations (98)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Washington University School of Medicine
St Louis, Missouri, United States