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

Completed · Phase 3

Conditions studied: Granulomatosis With Polyangiitis (Wegener's) (GPA), Microscopic Polyangiitis (MPA)

In brief

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.

Key facts

Study ID

NCT00987389

Run by

University of Pennsylvania

People needed

704

Starts

2010-05-01

Expected to finish

2017-08-01

Last updated by the study team

2020-05-26

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Boston University School of Medicine — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States
• Canberra Hospital — Garran, Australian Capital Territory, Australia
• Concord Repatriation General Hospital — Concord, New South Wales, Australia
• John Hunter Hospital, — New Lambton Heights, New South Wales, Australia
• Prince of Wales Hospital — Randwick, New South Wales, Australia
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
• Nambour Hospital — Nambour, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Flinders Medical Centre, — Adelaide, South Australia, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• St Vincent's Hospital — Fitzroy, Victoria, Australia
• The Geelong Hospital — Geelong, Victoria, Australia
• Austin Hospital — Heidelberg, Victoria, Australia
• The Royal Melbourne Hospital — Parkville, Victoria, Australia
• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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