UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009523 |
|---|---|
| Receipt number | R000010766 |
| Scientific Title | Plasma Exchange and glucocorticoids in anti-neutrophil cytoplasm antibody associated vasculitis: a randomized controlled trial. PEXIVAS |
| Date of disclosure of the study information | 2012/12/11 |
| Last modified on | 2020/02/16 12:51:31 |
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Basic information
Public title
Plasma Exchange and glucocorticoids in anti-neutrophil cytoplasm antibody associated vasculitis: a randomized controlled trial. PEXIVAS
Acronym
PEXIVAS
Scientific Title
Plasma Exchange and glucocorticoids in anti-neutrophil cytoplasm antibody associated vasculitis: a randomized controlled trial. PEXIVAS
Scientific Title:Acronym
PEXIVAS
Region
| Japan | North America | South America |
| Australia | Europe |
Condition
Condition
Granulomatosis With Polyangiitis (Wegener's) (GPA)
Microscopic Polyangiitis (MPA)
Classification by specialty
| Medicine in general | Pneumology | Nephrology |
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Composite of i)all-cause mortality or ii) End-stage renal disease
Key secondary outcomes
*Sustained remission
*Rate of serious infections
*Health-related quality of life using the SF-36 Physical Composite, Mental Composite and EQ-5D Index Score
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Experimental plasma exchange (PLEX) in addition to standard immunosuppressive therapy and standard-dose glucocorticoids (GC) taper.
Interventions/Control_2
Standard immunosuppressive therapy and standard-dose GC taper without PLEX.
Interventions/Control_3
Experimental PLEX in addition to standard immunosuppressive therapy and reduced-dose GC taper.
Interventions/Control_4
Standard immunosuppressive therapy and reduced-dose GC taper without PLEX.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. New or previous clinical diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions
AND
2. Positive test, at any point in the subject's course, by ELISA, for proteinase 3-ANCA or myeloperoxidase-ANCA
AND
3. Severe vasculitis defined by at least one of the following:
a. Renal involvement with both:
i. Renal biopsy demonstrating focal necrotizing glomerulonephritis or active urine sediment characterized by glomerular haematuria or red cell casts and proteinuria
AND
ii. eGFR <50 ml/min/1.73 m2
b. Pulmonary hemorrhage due to active vasculitis defined by:
i. A compatible chest x-ray or CT scan (diffuse pulmonary infiltrates)
AND
ii. The absence of an alternative explanation for all pulmonary infiltrates (e.g. volume overload or pulmonary infection)
AND
iii. At least one of the following:
1)Evidence of alveolar hemorrhage on bronchoscopic examination or increasingly bloody returns with bronchoalveolar lavage
2)Observed hemoptysis
3)Unexplained anemia (<10 g/dL) or documented drop in hemoglobin >1 g/dL)
4)Increased diffusing capacity of carbon dioxide
4. Provision of informed consent by patient or a surrogate decision maker
Key exclusion criteria
1. A diagnosis of vasculitis other than granulomatosis with polyangiitis or microscopic polyangiitis
2. Positive anti-glomerular basement membrane antibody test or renal biopsy demonstrating linear glomerular immunoglobulin deposition
3. Receipt of dialysis for >21 days immediately prior to randomization or prior renal transplant
4. Age <18 years
5. Pregnancy/Inability or unwillingness to comply with birth control
6. 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
7. A comorbidity or condition that, in the opinion of the investigator,precludes the use of cyclophosphamide/rituximab, glucocorticoids, or plasma exchange or absolutely mandates the use of plasma
exchange
8. Plasma exchange in 3 months prior to randomization
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shouichi Fujimoto |
Organization
University of Miyazaki Hospital
Division name
Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine, University of Miyazaki
Zip code
Address
5200 Kihara, Kiyotake-cho, Miyazaki 889-1692 Japan
TEL
0985-85-9761
fujimos@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiko Ito-Ihara |
Organization
Kyoto University Hospital
Division name
Institute for Advancement of Clinical and Translational Science
Zip code
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507 Japan
TEL
075-751-4739
Homepage URL
http://www.birmingham.ac.uk/research/activity/mds/trials/bctu/trials/renal/pexivas/index.aspx
itoshi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Cambridge University Hospitals NHS Foundation Trust, UK
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
European Vasculitis Study Group
Vasculitis Clinical Research Consortium
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00987389
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
2009-013220-24
Org. issuing International ID_2
EUDRACT
IND to MHLW
Institutions
Institutions
宮崎大学医学部附属病院 University of Miyazaki (宮崎県 Miyazaki)、田附興風会医学研究所北野病院 Kitano Hospital (大阪府 Osaka)、帝京大学医学部附属病院 Teikyo University（東京都 Tokyo)、地方独立行政法人 東京都健康長寿医療センター Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology (東京都 Tokyo), 京都大学医学部附属病院 Kyoto University Hospital (京都府、Kyoto), 筑波大学附属病院 Tsukuba University Hospital (茨城県、Ibaraki)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
http://www.birmingham.ac.uk/research/activity/mds/trials/bctu/trials/renal/pexivas/index.aspx
Publication of results
Published
Result
URL related to results and publications
https://www.nejm.org/doi/full/10.1056/NEJMoa1803537?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.
Number of participants that the trial has enrolled
704
Results
Ref:N Engl J Med. 2020;382:622-631.
Results date posted
| 2020 | Year | 02 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 02 | Month | 13 | Day |
Baseline Characteristics
Ref: N Engl J Med. 2020;382:622-631.
Participant flow
Ref: N Engl J Med. 2020;382:622-631.
Adverse events
Ref: N Engl J Med. 2020;382:622-631.
Outcome measures
Ref: N Engl J Med. 2020;382:622-631.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 30 | Day |
Other
Other related information
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;14:73.
Ito-Ihara T, Fujimoto S, Suzuki K, Endo T, Muso E on behalf of the PEXIVAS-JP Group.
Apheresis therapy for ANCA-associated vasculitis - Plasma Exchange and glucocorticoids in anti-neutrophil cytoplasm antibody associated vasculitis: a randomized controlled trial. (PEXIVAS)-.
Japanese Journal of Apheresis. 2015;34(2):120-5. (Japanese)
Management information
Registered date
| 2012 | Year | 12 | Month | 11 | Day |
Last modified on
| 2020 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010766
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