Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis (PEXIVAS) - Glucocorticoids
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|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.
|Condition or disease||Intervention/treatment||Phase|
|Granulomatosis With Polyangiitis (Wegener's) (GPA) Microscopic Polyangiitis (MPA)||Drug: Glucocorticoids - Standard Dose Drug: Glucocorticoids - Reduced Dose||Phase 3|
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;
- Plasma exchange - 7 exchanges and, either standard or low-dose glucocorticoids or
- No plasma exchange and, either standard or low-dose glucocorticoids
All studies will receive standard remission-induction therapy with either cyclophosphamide or rituximab.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||704 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial [Glucocorticoids]|
|Actual Study Start Date :||May 2010|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 31, 2017|
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
- Composite of i) all-cause mortality or ii) End-stage renal disease [ Time Frame: 2 years after the final subject is enrolled ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919825
|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|