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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2019
• Main ID: NCT03919825
• Date of registration: 15/04/2019
• Prospective Registration: No
• Primary sponsor: University of Pennsylvania
• Public title: Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis (PEXIVAS) - Glucocorticoids
• Scientific title: Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial [Glucocorticoids]
• Date of first enrolment: May 2010
• Target sample size: 704
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03919825
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Contacts

• Name: Michael Walsh, MD
• Affiliation: McMaster University

• Name: David Jayne, MD
• Affiliation: Cambridge University Hospitals NHS Foundation Trust

• Name: Peter Merkel, MD, MPH
• Affiliation: University of Pennsylvania

Key inclusion & exclusion criteria

Inclusion Criteria:

• 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:

1. Renal involvement with both:

- 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

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 (<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

Exclusion Criteria:

- A diagnosis of vasculitis other than granulomatosis with polyangiitis or microscopic
polyangiitis

- 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
transplant

- Age <15 years

- Pregnancy

- Inability or unwillingness to comply with birth control/abstinence

- 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



Age minimum: 15 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Granulomatosis With Polyangiitis (Wegener's) (GPA)

Microscopic Polyangiitis (MPA)

Intervention(s)

Drug: Glucocorticoids - Standard Dose

Drug: Glucocorticoids - Reduced Dose

Primary Outcome(s)

Composite of i) all-cause mortality or ii) End-stage renal disease [Time Frame: 2 years after the final subject is enrolled]

Secondary ID(s)

5524

Source(s) of Monetary Support

Please refer to primary and secondary sponsors