Clinical Trial: Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial
Brief 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 Summary:
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.
Sponsor: University of Pennsylvania
Current Primary Outcome:
- All-cause mortality [ Time Frame: 2 years after the final subject is enrolled ]
- End-stage renal disease [ Time Frame: 2 years after final subject is enrolled ]
Original Primary Outcome: Composite of i) all-cause mortality or ii) end-stage renal disease completion [ Time Frame: 2 years after the final patient is enrolled ]
Current Secondary Outcome:
- Sustained remission [ Time Frame: 2 years after the final subject is enrolled ]Remission that occurs before 6 months, and lasts without a first relapse until at least 12 months after randomization
- Rate of serious infections [ Time Frame: 12 months after first subject enrolled and at study end ]
- Health-related quality of life using the SF-36 Physical Composite, Mental Composite and EQ-5D Index Score [ Time Frame: 12 months after study enrollment is completed ]
Original Secondary Outcome: Sustained remission, all-cause mortality, end-stage renal disease, serious adverse events, medical outcomes survey short form - 36 (SF-36), EuroQoL EQ5D index score [ Time Frame: Remission that occurs before 6 months, and lasts without a first relapse until at least 12 months after randomization ]
Information By: University of Pennsylvania
Dates:
Date Received: September 23, 2009
Date Started: May 2010
Date Completion: April 2018
Last Updated: May 19, 2017
Last Verified: May 2017
