UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031863 |
|---|---|
| Receipt number | R000036385 |
| Scientific Title | The study to develop novel treatment for antibody-mediated rejection after organ transplantation. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/03/26 10:05:06 |
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Basic information
Public title
The study to develop novel treatment for antibody-mediated rejection after organ transplantation.
Acronym
The novel treatment for post-transplant antibody-mediated rejection.
Scientific Title
The study to develop novel treatment for antibody-mediated rejection after organ transplantation.
Scientific Title:Acronym
The novel treatment for post-transplant antibody-mediated rejection.
Region
| Japan |
Condition
Condition
post-transplant antibody-mediated rejection
Classification by specialty
| Surgery in general | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to treat the antibody-mediated rejection after organ transplantation with reducing the production of antibody from B lymphocyte, with using rituximab.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitized cases: the incidence of negativity of antibody, or the change of antibody titer
The cases with antibody-mediated rejection: organ function or pathological finding
Key secondary outcomes
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
Rituximab is intravenously administered with single dose of 375mg/m2.
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
Sensitized cases before transplantation:
Out patients and/or admitted patients.
Positivity of antibody for HLA, and awaiting for the organ transplantation including liver, heart, pancreas/islet, or small intestine.
Under fully informed consent with legal representative.
Cases with AMR:
Out patients and/or admitted patients.
With ongoing AMR after organ transplantation including liver, heart, pancreas/islet, or small intestine.
Under fully informed consent with legal representative.
Key exclusion criteria
The cases with active infection.
The cases with viable malignancy, excluding hepatocellular carcinoma which is rescued by liver transplantation.
Any cases which are considered as inadequate to entry the study.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Egawa |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery, Institute of Gastroenterology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku,Tokyo, 1628666, Japan
TEL
03-3353-8111
egawa@ige.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroto Egawa |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery, Institute of Gastroenterology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku,Tokyo, 1628666, Japan
TEL
03-3353-8111
Homepage URL
egawa@ige.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | 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
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 23 | 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
| 2018 | Year | 03 | Month | 23 | Day |
Last modified on
| 2018 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036385
