UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010944 |
|---|---|
| Receipt number | 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 10:26:42 |
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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
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
fujimos@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine, University of Miyazaki
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
