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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03919825
Recruitment Status Completed
First Posted April 18, 2019
Last update posted April 18, 2019
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 groups; 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 rituximab.
|Active Comparator: Glucocorticoids - Standard Dose
All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease following a standard regimen.
Drug: Glucocorticoids - Standard Dose
Subjects will receive glucocorticoids at a standard dose and will decrease following a standard regimen.
|Experimental: Glucocorticoids - Reduced Dose
All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease following a reduced dose regimen.
Drug: Glucocorticoids - Reduced Dose
Subjects' will receive glucocorticoids at a reduced dose and will decrease following a reduced dose regimen
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
• 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) AND - The absence of an alternative explanation for all pulmonary infiltrates (e.g. volume overload or pulmonary infection) AND 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 (1 g/dL)
- Increased diffusing capacity of carbon dioxide
- Provision of informed consent by patient or a surrogate decision maker
- 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 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
University of Pennsylvania
Principal Investigator: David Jayne, MD Cambridge University Hospitals NHS Foundation Trust
Principal Investigator: Peter Merkel, MD, MPH University of Pennsylvania
Principal Investigator: Michael Walsh, MD McMaster University