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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014222
Receipt No. R000016553
Scientific Title Low-dose glucocorticoids plus rituximab versus high-dose glucocorticoids plus rituximab for remission induction in ANCA-associated vasculitis; a multicentre, open label, randomised control trial
Date of disclosure of the study information 2014/08/01
Last modified on 2019/06/14

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Basic information
Public title Low-dose glucocorticoids plus rituximab versus high-dose glucocorticoids plus rituximab for remission induction in ANCA-associated vasculitis; a multicentre, open label, randomised control trial
Acronym LoVAS
Scientific Title Low-dose glucocorticoids plus rituximab versus high-dose glucocorticoids plus rituximab for remission induction in ANCA-associated vasculitis; a multicentre, open label, randomised control trial
Scientific Title:Acronym LoVAS
Region
Japan

Condition
Condition ANCA-associated vasculitis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate non-inferiority of efficacy of low-dose glucocorticoids plus rituximab against high-dose glucocorticoids plus rituximab in remission induction in ANCA-associated vasculitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Proportion of the patients achieving remission within 6 months
Key secondary outcomes <Efficacy>
(1) Time to remission
(2) Overall survival, disease free survival, time to end-stage renal disease, time to the first serious adverse event
(3) Proportions of death, relapse, end-stage renal disease and the composite of these (6 months and 24 months)
(4) Proportions of severe relapse
(5)Proportions of the patients achieving remission and stopping glucocorticoids
(6) BVAS ver3
(7) VDI
(8) SF-36
(9) Patient global assessment (visualised analogue scale)
(10) accumulative dose of glucocorticoids
<safety>
(1) Numbers of events of adverse events/serious adverse events, proportions of the patients with adverse events/serious adverse events
(2) Proportions of the patients with new onset diabetes mellitus, hypertension and hyperlipidemia
(3) Proportion of the patients with new onset insomnia
(4) Proportion of the patients with new onset bone fracture, bone density
(5) Number of infections, proportions of the patients with infection
<Exploratory>
(1) Serum immunoglobulin levels
(2) Peripheral blood B cell counts
(3) MPO-/PR3-ANCA levels

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 low-dose glucocorticoids plus rituximab
(prednisolone0.5mg/kg/day+rituximab375mg/m2/wx4)
Interventions/Control_2 high-dose glucocorticoids plus rituximab
(prednisolone1.0mg/kg/day+rituximab375mg/m2/wx4)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria To be included in the trial patients must must have:
(1) Provision of written informed consent by a patient or a surrogate decision maker
(2) Age=>20 years
(3) New clinical diagnosis of ANCA-associated vasculitis (granulomatosis with polyangiitis, microscopic polyangiitis or renal limited vasculitis) consistent with the 2012 Chapel Hill consensus definitions
(4) Positive test by ELISA for proteinase 3-ANCA or myeloperoxidase-ANCA
Key exclusion criteria The presence of any of the following will preclude patient inclusion:
(1) Prior treatment for ANCA-associated vasculitis before trial entry
(2) ANCA-associated vasculitis related glomerulonephritis (eGFR<15ml/min) or alveolar hemorrhage (oxygen inhalation >2L/min)
(3) Presence of another multisystem autoimmune disease
(4) Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection
(5) Desire to bear children, pregnancy or lactating
(6) History of malignancy within the past 5 years or any evidence of persistent malignancy
(7) Ongoing or recent (last 1 year) evidence of active tuberculosis
(8) Severe allergy or anaphylaxis to monoclonal antibody therapy
(9) Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg
(10) Any biological B cell depleting agent (such as rituximab or belimumab) within the past 6 months
(11) Other conditions, in the investigator's opinion, inappropriate for the trial entry
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Nakajima
Organization Chiba University Hospital
Division name Allergy and Clinical Immunology
Zip code 2608670
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan
TEL 043-222-7171
Email nakajimh@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Shunsuke
Middle name
Last name Furuta
Organization Chiba University Hospital
Division name Clinical Research Center
Zip code 2608670
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan
TEL 043-222-7171
Homepage URL
Email shfuruta@chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization Chiba University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University Hospital
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan
Tel 043-222-7171
Email shiken@office.chiba-u.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 06 Month 18 Day
Date of IRB
2014 Year 06 Month 18 Day
Anticipated trial start date
2014 Year 09 Month 30 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 10 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016553

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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