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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Plasma Exchange
No Plasma Exchange
Glucocorticoids [Standard Dose]
Glucocorticoids [Reduced Dose]
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Granulomatosis With Polyangiitis (Wegener's) (GPA) focused on measuring Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Wegener's, ANCA-Associated Vasculitis, GPA, MPA, Treatment, Plasma exchange, Glucocorticoids, ANCA-Positive

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 characterized by both of the following:

      • 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 serum 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 at time of study entry
  • 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
  • Plasma exchange in 3 months prior to randomization

Sites / Locations

  • Cedars-Sinai Medical Center
  • Boston University School of Medicine
  • Mayo Clinic
  • Washington University School of Medicine
  • University of North Carolina
  • Cleveland Clinic
  • University of Pennsylvania
  • University of Pittsburgh
  • University of Virginia
  • Canberra Hospital
  • Concord Repatriation General Hospital
  • John Hunter Hospital,
  • Prince of Wales Hospital
  • Royal North Shore Hospital
  • Royal Brisbane and Women's Hospital
  • Nambour Hospital
  • Princess Alexandra Hospital
  • Flinders Medical Centre,
  • Royal Adelaide Hospital
  • Royal Hobart Hospital
  • Monash Medical Centre
  • St Vincent's Hospital
  • The Geelong Hospital
  • Austin Hospital
  • The Royal Melbourne Hospital
  • Fremantle Hospital,
  • Gold Coast Hospital
  • University Hospitals Leuven
  • University of Calgary
  • University of Alberta
  • St Paul's Hospital
  • St Joseph's Hospital
  • London Health Sciences Centre
  • The Ottawa Hospital
  • Mount Sinai Hospital
  • St Michael's Hospital
  • Hopital Saint-Luc
  • General Faculty Hospital
  • Aarhus University Hospital
  • Herlev Hospital
  • Rigshospitalet
  • Holstebro Hospital and University of Aarhus
  • Centre Hospitalier de Boulogne
  • CHRU Brest Hopital La Cavale Blanche
  • CHU Brest
  • CHU Caen - Nephrology Department
  • CHU Clermont-Ferrand
  • Colmar Hospital - Nephrology
  • CHU D'Angers
  • Centre Hospitalier Universitaire de Grenoble
  • Hopital Site Sainte Blandine
  • Centre Hospitalier de Mulhouse
  • Hopital Bichat Claude Bernard
  • Hopital Cochin
  • Hopital Europeen Georges-Pompidou
  • Centre Hospitalier de la Region d'Annecy
  • CHU De Toulouse-Hotel Dieu Saint Jacques
  • CHU Hopital Bretonneau
  • Centre Hospitalier de Valenciennes
  • Hippokration Hospital
  • University of Brescia
  • Azienda Ospedaliero Universitaria di Parma
  • University of Tsukuba
  • Kyoto University Hospital
  • University of Miyazaki Hospital
  • Kitano Hospital
  • Teikyo University Hospital
  • Tokyo Metropolitan Geriatric Hospital
  • Instituto Nacional de Enfermedades Respiratorias
  • North Shore Hospital
  • Dunedin Hospital
  • Waikato Hospital
  • University Hospital North Norway HF
  • St Olavs Hospital, Trondheim University Hospital
  • Linkoping University Hospital
  • Skane University Hospital
  • Karolinska Institute
  • Western Infirmary
  • Aberdeen Royal Infirmary
  • Queen Elizabeth Hospital
  • Brighton and Sussex University Hospitals
  • Addenbrooke's Hospital
  • Kent and Canterbury Hospital
  • University Hospitals Coventry and Warwickshire NHS Trust
  • Royal Infirmary of Edinburgh
  • Royal Devon & Exeter Hospital (Wonford)
  • St James's University Hospital
  • Royal Liverpool University Hospital
  • Royal Free Hospital
  • The Royal London Hospital
  • St. George's Hospital
  • Hammersmith Hospital
  • Manchester Royal Infirmary
  • Freeman Hospital
  • Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
  • Churchill Hospital
  • Royal Preston Hospital
  • Royal Berkshire Hospital, Reading

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Plasma Exchange with Standard Glucocorticoids

No Plasma Exchange with Standard Glucocorticoids

Plasma Exchange with Reduced-Dose Glucocorticoids

No Plasma Exchange with Reduced-Dose Glucocorticoids

Arm Description

Participants in this arm undergo plasma exchange and take a standard glucocorticoid dose.

Participants in this arm do not undergo plasma exchange and take a standard glucocorticoid dose.

Participants in this arm undergo plasma exchange and take a reduced glucocorticoid dose.

Participants in this arm do not undergo plasma exchange and take a reduced glucocorticoid dose.

Outcomes

Primary Outcome Measures

Composite of i) All-cause Mortality or ii) End-stage Renal Disease
The primary outcome was a composite of death from any cause or end-stage renal disease (ESRD), defined as ≥12 continuous weeks of renal replacement therapy.

Secondary Outcome Measures

Number of Participants With Sustained Remission
Remission that occurs before 6 months, and lasts without a first relapse until at least 12 months after randomization
Rate of Serious Infection Events
Serious infections defined as an infectious syndrome that requires intravenous antibiotics or hospitalization for treatment.
Health-related Quality of Life Using the SF-36 Physical Composite
Quality of life was measured using the 36-item Short Form (SF-36) physical composite scores. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Health-related Quality of Life Using the SF-36 Mental Composite
Quality of life was measured using the 36-item Short Form (SF-36) mental composite scores. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Health-related Quality of Life Using the EQ-5D Index Descriptive System
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Health state index scores generally range from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating higher health utility.

Full Information

First Posted
September 23, 2009
Last Updated
May 19, 2020
Sponsor
University of Pennsylvania
Collaborators
Cambridge University Hospitals NHS Foundation Trust, University of Birmingham, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00987389
Brief Title
Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis
Acronym
PEXIVAS
Official Title
Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Cambridge University Hospitals NHS Foundation Trust, University of Birmingham, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Granulomatosis With Polyangiitis (Wegener's) (GPA), Microscopic Polyangiitis (MPA)
Keywords
Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Wegener's, ANCA-Associated Vasculitis, GPA, MPA, Treatment, Plasma exchange, Glucocorticoids, ANCA-Positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
704 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plasma Exchange with Standard Glucocorticoids
Arm Type
Experimental
Arm Description
Participants in this arm undergo plasma exchange and take a standard glucocorticoid dose.
Arm Title
No Plasma Exchange with Standard Glucocorticoids
Arm Type
Active Comparator
Arm Description
Participants in this arm do not undergo plasma exchange and take a standard glucocorticoid dose.
Arm Title
Plasma Exchange with Reduced-Dose Glucocorticoids
Arm Type
Experimental
Arm Description
Participants in this arm undergo plasma exchange and take a reduced glucocorticoid dose.
Arm Title
No Plasma Exchange with Reduced-Dose Glucocorticoids
Arm Type
Active Comparator
Arm Description
Participants in this arm do not undergo plasma exchange and take a reduced glucocorticoid dose.
Intervention Type
Procedure
Intervention Name(s)
Plasma Exchange
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Plasma Exchange
Intervention Description
No plasma exchange.
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids [Standard Dose]
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids [Reduced Dose]
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite of i) All-cause Mortality or ii) End-stage Renal Disease
Description
The primary outcome was a composite of death from any cause or end-stage renal disease (ESRD), defined as ≥12 continuous weeks of renal replacement therapy.
Time Frame
Time frame varied by subject: minimum of 1 year - maximum of 7 years
Secondary Outcome Measure Information:
Title
Number of Participants With Sustained Remission
Description
Remission that occurs before 6 months, and lasts without a first relapse until at least 12 months after randomization
Time Frame
Time frame varied by subject: minimum of 1 year - maximum of 7 years
Title
Rate of Serious Infection Events
Description
Serious infections defined as an infectious syndrome that requires intravenous antibiotics or hospitalization for treatment.
Time Frame
Time frame varied by subject: minimum of 1 year - maximum of 7 years
Title
Health-related Quality of Life Using the SF-36 Physical Composite
Description
Quality of life was measured using the 36-item Short Form (SF-36) physical composite scores. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame
12 months
Title
Health-related Quality of Life Using the SF-36 Mental Composite
Description
Quality of life was measured using the 36-item Short Form (SF-36) mental composite scores. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life.
Time Frame
12 months
Title
Health-related Quality of Life Using the EQ-5D Index Descriptive System
Description
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Health state index scores generally range from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating higher health utility.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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: Renal involvement characterized by both of the following: 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 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 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 serum 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 at time of study entry 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 Plasma exchange in 3 months prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Jayne, MD
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Merkel, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Walsh, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
John Hunter Hospital,
City
New Lambton Heights
State/Province
New South Wales
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
Nambour Hospital
City
Nambour
State/Province
Queensland
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Flinders Medical Centre,
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
St Vincent's Hospital
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
The Geelong Hospital
City
Geelong
State/Province
Victoria
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
Fremantle Hospital,
City
Fremantle,
State/Province
Western Australia
Country
Australia
Facility Name
Gold Coast Hospital
City
Southport
Country
Australia
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
St Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St Joseph's Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hopital Saint-Luc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
General Faculty Hospital
City
Prague
Country
Czechia
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Herlev Hospital
City
Copenhagen
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Holstebro Hospital and University of Aarhus
City
Holstebro
Country
Denmark
Facility Name
Centre Hospitalier de Boulogne
City
Boulogne-sur-Mer
Country
France
Facility Name
CHRU Brest Hopital La Cavale Blanche
City
Brest
Country
France
Facility Name
CHU Brest
City
Brest
Country
France
Facility Name
CHU Caen - Nephrology Department
City
Caen
Country
France
Facility Name
CHU Clermont-Ferrand
City
Clermont Ferrand
Country
France
Facility Name
Colmar Hospital - Nephrology
City
Colmar
Country
France
Facility Name
CHU D'Angers
City
D'Angers
Country
France
Facility Name
Centre Hospitalier Universitaire de Grenoble
City
Grenoble
Country
France
Facility Name
Hopital Site Sainte Blandine
City
Metz
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
Country
France
Facility Name
Hopital Bichat Claude Bernard
City
Paris
Country
France
Facility Name
Hopital Cochin
City
Paris
Country
France
Facility Name
Hopital Europeen Georges-Pompidou
City
Paris
Country
France
Facility Name
Centre Hospitalier de la Region d'Annecy
City
Pringy
Country
France
Facility Name
CHU De Toulouse-Hotel Dieu Saint Jacques
City
Toulouse
Country
France
Facility Name
CHU Hopital Bretonneau
City
Tours
Country
France
Facility Name
Centre Hospitalier de Valenciennes
City
Valenciennes
Country
France
Facility Name
Hippokration Hospital
City
Thessaloniki
Country
Greece
Facility Name
University of Brescia
City
Brescia
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
Country
Italy
Facility Name
University of Tsukuba
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8572
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
University of Miyazaki Hospital
City
Miyazaki
Country
Japan
Facility Name
Kitano Hospital
City
Osaka
Country
Japan
Facility Name
Teikyo University Hospital
City
Tokyo
Country
Japan
Facility Name
Tokyo Metropolitan Geriatric Hospital
City
Tokyo
Country
Japan
Facility Name
Instituto Nacional de Enfermedades Respiratorias
City
Mexico City
Country
Mexico
Facility Name
North Shore Hospital
City
Takapuna
State/Province
Auckland
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
University Hospital North Norway HF
City
Tromsø
Country
Norway
Facility Name
St Olavs Hospital, Trondheim University Hospital
City
Trondheim
Country
Norway
Facility Name
Linkoping University Hospital
City
Linkoping
Country
Sweden
Facility Name
Skane University Hospital
City
Malmo
Country
Sweden
Facility Name
Karolinska Institute
City
Stockholm
Country
Sweden
Facility Name
Western Infirmary
City
Glasgow
State/Province
Scotland
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TQ
Country
United Kingdom
Facility Name
Brighton and Sussex University Hospitals
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB22QQ
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
Country
United Kingdom
Facility Name
University Hospitals Coventry and Warwickshire NHS Trust
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Royal Devon & Exeter Hospital (Wonford)
City
Exeter
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
SE1 2PR
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
Country
United Kingdom
Facility Name
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
City
Oxford
ZIP/Postal Code
OX3 7LD
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Royal Berkshire Hospital, Reading
City
Reading
ZIP/Postal Code
RG1 5AQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23497590
Citation
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.
Results Reference
background
PubMed Identifier
32053298
Citation
Walsh M, Merkel PA, Peh CA, Szpirt WM, Puechal X, Fujimoto S, Hawley CM, Khalidi N, Flossmann O, Wald R, Girard LP, Levin A, Gregorini G, Harper L, Clark WF, Pagnoux C, Specks U, Smyth L, Tesar V, Ito-Ihara T, de Zoysa JR, Szczeklik W, Flores-Suarez LF, Carette S, Guillevin L, Pusey CD, Casian AL, Brezina B, Mazzetti A, McAlear CA, Broadhurst E, Reidlinger D, Mehta S, Ives N, Jayne DRW; PEXIVAS Investigators. Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis. N Engl J Med. 2020 Feb 13;382(7):622-631. doi: 10.1056/NEJMoa1803537.
Results Reference
result
PubMed Identifier
36155131
Citation
Jayne D, Walsh M, Merkel PA, Peh CA, Szpirt W, Puechal X, Fujimoto S, Hawley C, Khalidi N, Jones R, Flossmann O, Wald R, Girard L, Levin A, Gregorini G, Harper L, Clark W, Pagnoux C, Specks U, Smyth L, Ito-Ihara T, de Zoysa J, Brezina B, Mazzetti A, McAlear CA, Reidlinger D, Mehta S, Ives N, Brettell EA, Jarrett H, Wheatley K, Broadhurst E, Casian A, Pusey CD. Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT. Health Technol Assess. 2022 Sep;26(38):1-60. doi: 10.3310/PNXB5040.
Results Reference
derived
Links:
URL
http://www.rarediseasesnetwork.org/vcrc
Description
Related Info
URL
http://www.vasculitis.org/
Description
Related Info

Learn more about this trial

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

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