Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis

Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:15 - Any
Start Date:May 2010
End Date:August 2017

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Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial

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 whether a reduced cumulative dosing regimen of glucocorticoids is
as effective as a standard disease regimen.

The FDA-OOPD is one of the funding sources for this study.

Granulomatosis with polyangiitis (Wegener's) (WG) and microscopic polyangiitis (MPA) are
syndromes of primary systemic vasculitis associated with anti-neutrophil cytoplasm antibodies
(ANCA). Together, these syndromes are grouped as ANCA-associated systemic vasculitis (AAV).

Plasma exchange, a method of rapidly removing potentially pathogenic ANCA and other mediators
of inflammation and coagulation, has shown promise as an adjunctive therapy in AAV to improve
early disease control and improve rates of renal recovery in severe disease. Glucocorticoids
(steroids) are a standard of care in the treatment of AAV. High doses of glucocorticoids
early in disease, although reduce disease activity due to their anti-inflammatory and
immunosuppressive properties, also increase the risk of infection, particularly in the
elderly and in the presence of uremia. There is no randomized trial data to guide
glucocorticoids dosing.

Patients with severe new or relapsing AAV and pulmonary hemorrhage and/or renal disease will
be eligible for this trial.

Subjects participating in this study will be randomized to receive one of the following

1. Plasma exchange - 7 exchanges and, either standard or low-dose glucocorticoids or

2. No plasma exchange and, either standard or low-dose glucocorticoids

All studies will receive standard remission-induction therapy with either cyclophosphamide or

Inclusion Criteria:

• New or previous clinical diagnosis of granulomatosis with polyangiitis or microscopic
polyangiitis consistent with the Chapel-Hill consensus definitions


• Positive test for proteinase 3-ANCA or myeloperoxidase-ANCA


- Severe vasculitis defined by at least one of the following:

1. Renal involvement with both:

- Renal biopsy demonstrating focal necrotizing glomerulonephritis or active
urine sediment characterized by glomerular haematuria or red cell casts and


- eGFR <50 ml/min/1.73 m2

2. Pulmonary hemorrhage due to active vasculitis defined by:

- A compatible chest x-ray or CT scan (diffuse pulmonary infiltrates)


- The absence of an alternative explanation for all pulmonary infiltrates
(e.g. volume overload or pulmonary infection)


3. 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 Criteria:

- A diagnosis of vasculitis other than granulomatosis with polyangiitis or microscopic

- Positive 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

- Age <15 years

- Pregnancy

- Inability or unwillingness to comply with birth control/abstinence

- 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
We found this trial at
72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Principal Investigator: Paul Monach, MD, PhD
Phone: 617-414-2512
Boston University School of Medicine A leader in medical education and research, Boston University School...
Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
Cleveland, OH
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
Los Angeles, CA
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
Pittsburgh, PA
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
Chapel Hill, NC
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
Charlottesville, VA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-614-4401
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
Philadelphia, PA
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Rochester, Minnesota 55905
Rochester, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
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