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Trial record 13 of 46 for:    "Microscopic polyangiitis"

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987389
First Posted: September 30, 2009
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Birmingham
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania
September 23, 2009
September 30, 2009
October 26, 2017
May 2010
April 2018   (Final data collection date for primary outcome measure)
  • 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 ]
Composite of i) all-cause mortality or ii) end-stage renal disease completion [ Time Frame: 2 years after the final patient is enrolled ]
Complete list of historical versions of study NCT00987389 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Granulomatosis With Polyangiitis (Wegener's) (GPA)
  • Microscopic Polyangiitis (MPA)
  • 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.
  • Drug: Glucocorticoids
    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 either a standard regimen or a reduced regimen.
  • No Plasma Exchange
    Participants in this arm do not undergo plasma exchange
    Intervention: Drug: Glucocorticoids
  • Experimental: Plasma Exchange
    Interventions:
    • Procedure: Plasma Exchange
    • Drug: Glucocorticoids
Walsh M, Merkel PA, Peh CA, Szpirt W, Guillevin L, Pusey CD, De Zoysa J, Ives N, Clark WF, Quillen K, Winters JL, Wheatley K, Jayne D; PEXIVAS Investigators. Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis (PEXIVAS): protocol for a randomized controlled trial. Trials. 2013 Mar 14;14:73. doi: 10.1186/1745-6215-14-73.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
704
April 2018
April 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Czechia,   Denmark,   France,   Greece,   Italy,   Japan,   Mexico,   New Zealand,   Norway,   Sweden,   United Kingdom,   United States
Czech Republic
 
NCT00987389
PEXIVAS
R01FD00351604 ( Other Grant/Funding Number: Food and Drug Administration (FDA) )
Yes
Not Provided
Not Provided
Peter Merkel, University of Pennsylvania
University of Pennsylvania
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • University of Birmingham
  • Cambridge University Hospitals NHS Foundation Trust
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
Study Chair: Xavier Puéchal, MD, PhD Assistance Publique - Hôpitaux de Paris
University of Pennsylvania
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP