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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

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

Clinicaltrials.gov identifier NCT03919825

Recruitment Status Completed

First Posted April 18, 2019

Last update posted April 18, 2019

Study Description

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.

  • Condition or Disease:Granulomatosis With Polyangiitis (Wegener's) (GPA)
    Microscopic Polyangiitis (MPA)
  • Intervention/Treatment: Drug: Glucocorticoids - Standard Dose
    Drug: Glucocorticoids - Reduced Dose
  • Phase: Phase 3
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 704 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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 2017
Arms and interventions
Arm Intervention/treatment
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
Outcome Measures
  • Primary Outcome Measures: 1. Composite of i) all-cause mortality or ii) End-stage renal disease [ Time Frame: 2 years after the final subject is enrolled ]
Eligibility Criteria
  • Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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 (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 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

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

University of Pennsylvania

Investigators

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

More Information
  • Responsible Party: University of Pennsylvania
  • ClinicalTrials.gov Identifier: NCT03919825 History of Changes
  • Other Study ID Numbers: 5524
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: April 18, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by University of Pennsylvania: Vasculitis
  • Additional relevant MeSH terms: Granulomatosis with Polyangiitis
    Microscopic Polyangiitis
    Vasculitis
    Systemic Vasculitis