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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010944
Receipt No. R000012385
Scientific Title LCAP for ANCA-associated vasculitis presenting with rapidly progressive glomerulonephritis
Date of disclosure of the study information 2013/06/13
Last modified on 2018/12/16

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Basic information
Public title LCAP for ANCA-associated vasculitis presenting with rapidly progressive glomerulonephritis
Acronym LCAP for AAV
Scientific Title LCAP for ANCA-associated vasculitis presenting with rapidly progressive glomerulonephritis
Scientific Title:Acronym LCAP for AAV
Region
Japan

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

Objectives
Narrative objectives1 1. Evaluation of renal and life survivaldue to a combined therapy with glucocorticoid and LCAP for AAV presenting with RPGN
2. Evaluation of a redcution of glucocorticoid dosage and side effects including infection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes 1. improvement of serum creatinine
2. life survival at 6 months after treatment
Key secondary outcomes 1. improvement of CRP
2. life survival at one month after treatment
3. renal prognosis
4. change of GFR
5. improvement of lung lesion
6. occurrence of infection
7. a kind and frequency of sode effects

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 5 times of LCAP (two times for one week)
Interventions/Control_2
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1. new onset of AAV

and

2. RPGN
Key exclusion criteria 1. WBC and Plt counts lower than 3000/mm3 and 100,000/mm3, respectively
2. history of allergic reaction to FOY
3. severe cardiovascular, liver, lung, metabolic, neurologic or infectious diseases
4. prescription of ACEI
5. recent history of plasmapheresis

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shouichi Fujimoto
Organization University of Miyazaki
Division name Department of Hemovascular Medicine and Artificial Organs
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Japan
TEL 0985859761
Email fujimos@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shouichi Fujimoto
Organization University of Miyazaki
Division name Department of Hemovascular Medicine and Artificial Organs
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Japan
TEL 0985859761
Homepage URL
Email fujimos@med.miyazaki-u.ac.jp

Sponsor
Institute Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine, University of Miyazaki
Institute
Department

Funding Source
Organization Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine, University of Miyazaki
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 宮崎大学医学部附属病院、県立宮崎病院、県立延岡病院、古賀総合病院、宮崎江南病院、大分大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 13 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
LCAP might be useful for mild cases with 
ANCA vasculitis. However, registered cases were small, and statistical evaluation 
could not be done.
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 Terminated
Date of protocol fixation
2013 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2017 Year 08 Month 22 Day
Date of closure to data entry
2017 Year 08 Month 22 Day
Date trial data considered complete
2017 Year 08 Month 22 Day
Date analysis concluded
2017 Year 08 Month 22 Day

Other
Other related information

Management information
Registered date
2013 Year 06 Month 12 Day
Last modified on
2018 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012385

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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