UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013102 |
|---|---|
| Receipt number | R000015284 |
| Scientific Title | Efficacy of Zoledronate for RAS associated ALPS like disease (RALD) |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2017/10/12 18:13:06 |
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Basic information
Public title
Efficacy of Zoledronate for RAS associated ALPS like disease (RALD)
Acronym
Zoledronate for RALD
Scientific Title
Efficacy of Zoledronate for RAS associated ALPS like disease (RALD)
Scientific Title:Acronym
Zoledronate for RALD
Region
| Japan |
Condition
Condition
RAS associated ALPS like disease (RALD)
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of efficacy of zoledronate for RALD
Basic objectives2
Others
Basic objectives -Others
Reduction of immunosuppressive agents including steroid
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alleviation of autoimmunity
Key secondary outcomes
Reduction of immunosuppressive agents including steroid
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
| Medicine |
Interventions/Control_1
intravenous drip infusion of Zoledronate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) RAS associated ALPS like disease
2) Performance Status 0-2
3) CTCAE < Grade I
4) Written informed consent is obtained from gurdian in case of children
Key exclusion criteria
1) Pregnant women and during breast feeding.
2) Uncontrollable infection
3) Serious complication such as heart, kidney and liver failure.
4) Malignancy (except for juvenile myelomonocytic leukemia)
5) Dental disease need to be treated.
6) One who is not suitable by doctor's decision..
7) One who attended other clinical study.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Takagi |
Organization
Tokyo Medical and Dental Univeristy
Division name
Pediatrics
Zip code
Address
Yushima1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5249
m.takagi.ped@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Takagi |
Organization
Tokyo Medical and Dental Univeristy
Division name
Pediatrics
Zip code
Address
Yushima1-5-45, Bunkyo-ku, Tokyo
TEL
03-5803-5249
Homepage URL
m.takagi.ped@tmd.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
MHLW The Specified Disease Treatment Research Program
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
東京医科歯科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 07 | Day |
Last modified on
| 2017 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015284
