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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00987389




Registration number
NCT00987389
Ethics application status
Date submitted
23/09/2009
Date registered
30/09/2009
Date last updated
26/05/2020

Titles & IDs
Public title
Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis
Scientific title
Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial
Secondary ID [1] 0 0
R01FD00351604
Secondary ID [2] 0 0
PEXIVAS
Universal Trial Number (UTN)
Trial acronym
PEXIVAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Granulomatosis With Polyangiitis (Wegener's) (GPA) 0 0
Microscopic Polyangiitis (MPA) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Plasma Exchange
Other interventions - No Plasma Exchange
Treatment: Drugs - Glucocorticoids [Standard Dose]
Treatment: Drugs - Glucocorticoids [Reduced Dose]

Experimental: Plasma Exchange with Standard Glucocorticoids - Participants in this arm undergo plasma exchange and take a standard glucocorticoid dose.

Active comparator: No Plasma Exchange with Standard Glucocorticoids - Participants in this arm do not undergo plasma exchange and take a standard glucocorticoid dose.

Experimental: Plasma Exchange with Reduced-Dose Glucocorticoids - Participants in this arm undergo plasma exchange and take a reduced glucocorticoid dose.

Active comparator: No Plasma Exchange with Reduced-Dose Glucocorticoids - Participants in this arm do not undergo plasma exchange and take a reduced glucocorticoid dose.


Treatment: Surgery: 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.

Other interventions: No Plasma Exchange
No plasma exchange.

Treatment: Drugs: Glucocorticoids [Standard Dose]
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.

Treatment: Drugs: Glucocorticoids [Reduced Dose]
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.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of i) All-cause Mortality or ii) End-stage Renal Disease
Timepoint [1] 0 0
Time frame varied by subject: minimum of 1 year - maximum of 7 years
Secondary outcome [1] 0 0
Number of Participants With Sustained Remission
Timepoint [1] 0 0
Time frame varied by subject: minimum of 1 year - maximum of 7 years
Secondary outcome [2] 0 0
Rate of Serious Infection Events
Timepoint [2] 0 0
Time frame varied by subject: minimum of 1 year - maximum of 7 years
Secondary outcome [3] 0 0
Health-related Quality of Life Using the SF-36 Physical Composite
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Health-related Quality of Life Using the SF-36 Mental Composite
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Health-related Quality of Life Using the EQ-5D Index Descriptive System
Timepoint [5] 0 0
12 months

Eligibility
Key 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
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2017
Sample size
Target
Accrual to date
Final
704
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
John Hunter Hospital, - New Lambton Heights
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [7] 0 0
Nambour Hospital - Nambour
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Flinders Medical Centre, - Adelaide
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [12] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [13] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [14] 0 0
The Geelong Hospital - Geelong
Recruitment hospital [15] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [16] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [17] 0 0
Fremantle Hospital, - Fremantle,
Recruitment hospital [18] 0 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- New Lambton Heights
Recruitment postcode(s) [4] 0 0
- Randwick
Recruitment postcode(s) [5] 0 0
- St. Leonards
Recruitment postcode(s) [6] 0 0
- Herston
Recruitment postcode(s) [7] 0 0
- Nambour
Recruitment postcode(s) [8] 0 0
- Woolloongabba
Recruitment postcode(s) [9] 0 0
- Adelaide
Recruitment postcode(s) [10] 0 0
- Hobart
Recruitment postcode(s) [11] 0 0
- Clayton
Recruitment postcode(s) [12] 0 0
- Fitzroy
Recruitment postcode(s) [13] 0 0
- Geelong
Recruitment postcode(s) [14] 0 0
- Heidelberg
Recruitment postcode(s) [15] 0 0
- Parkville
Recruitment postcode(s) [16] 0 0
- Fremantle,
Recruitment postcode(s) [17] 0 0
- Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Czechia
State/province [14] 0 0
Prague
Country [15] 0 0
Denmark
State/province [15] 0 0
Aarhus
Country [16] 0 0
Denmark
State/province [16] 0 0
Copenhagen
Country [17] 0 0
Denmark
State/province [17] 0 0
Holstebro
Country [18] 0 0
France
State/province [18] 0 0
Boulogne-sur-Mer
Country [19] 0 0
France
State/province [19] 0 0
Brest
Country [20] 0 0
France
State/province [20] 0 0
Caen
Country [21] 0 0
France
State/province [21] 0 0
Clermont Ferrand
Country [22] 0 0
France
State/province [22] 0 0
Colmar
Country [23] 0 0
France
State/province [23] 0 0
D'Angers
Country [24] 0 0
France
State/province [24] 0 0
Grenoble
Country [25] 0 0
France
State/province [25] 0 0
Metz
Country [26] 0 0
France
State/province [26] 0 0
Mulhouse
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Pringy
Country [29] 0 0
France
State/province [29] 0 0
Toulouse
Country [30] 0 0
France
State/province [30] 0 0
Tours
Country [31] 0 0
France
State/province [31] 0 0
Valenciennes
Country [32] 0 0
Greece
State/province [32] 0 0
Thessaloniki
Country [33] 0 0
Italy
State/province [33] 0 0
Brescia
Country [34] 0 0
Italy
State/province [34] 0 0
Parma
Country [35] 0 0
Japan
State/province [35] 0 0
Ibaraki
Country [36] 0 0
Japan
State/province [36] 0 0
Kyoto
Country [37] 0 0
Japan
State/province [37] 0 0
Miyazaki
Country [38] 0 0
Japan
State/province [38] 0 0
Osaka
Country [39] 0 0
Japan
State/province [39] 0 0
Tokyo
Country [40] 0 0
Mexico
State/province [40] 0 0
Mexico City
Country [41] 0 0
New Zealand
State/province [41] 0 0
Auckland
Country [42] 0 0
New Zealand
State/province [42] 0 0
Dunedin
Country [43] 0 0
New Zealand
State/province [43] 0 0
Hamilton
Country [44] 0 0
Norway
State/province [44] 0 0
Tromsø
Country [45] 0 0
Norway
State/province [45] 0 0
Trondheim
Country [46] 0 0
Sweden
State/province [46] 0 0
Linkoping
Country [47] 0 0
Sweden
State/province [47] 0 0
Malmo
Country [48] 0 0
Sweden
State/province [48] 0 0
Stockholm
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Scotland
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Aberdeen
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Birmingham
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Brighton
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Cambridge
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Canterbury
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Coventry
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Edinburgh
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Exeter
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Leeds
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Liverpool
Country [60] 0 0
United Kingdom
State/province [60] 0 0
London
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Manchester
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Newcastle
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Oxford
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Preston
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Reading

Funding & Sponsors
Primary sponsor type
Other
Name
University of Pennsylvania
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cambridge University Hospitals NHS Foundation Trust
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Birmingham
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Jayne, MD
Address 0 0
Cambridge University Hospitals NHS Foundation Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Walsh M, Merkel PA, Peh CA, Szpirt WM, Puechal X, ... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00987389