NCT00987389

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 704 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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 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.

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, 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.

Conditions

• Granulomatosis With Polyangiitis (Wegener's) (GPA)
• Microscopic Polyangiitis (MPA)

Interventions

Type	Name	Description
PROCEDURE	Plasma Exchange	Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute.
OTHER	No Plasma Exchange	No plasma exchange.
DRUG	Glucocorticoids [Standard Dose]	During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. 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 [Reduced Dose]	During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease following a reduced regimen.

Timeline

• Start date: 2010-05-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2009-09-30
• Last updated: 2020-05-26
• Results posted: 2020-05-26

Locations

98 sites across 15 countries: United States, Australia, Belgium, Canada, Czechia, Denmark, France, Greece, Italy, Japan, Mexico, New Zealand, Norway, Sweden, United Kingdom