UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023064 |
|---|---|
| Receipt number | R000026559 |
| Scientific Title | To control antibody mediated rejection following kidney and liver transplantation in ABO-incompatible, donor specific antibody positive patients by using rituximab, proteasome inhibitor, complement inhibitor, and immunoglobulin administration |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2020/01/09 09:56:57 |
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Basic information
Public title
To control antibody mediated rejection following kidney and liver transplantation in ABO-incompatible, donor specific antibody positive patients by using rituximab, proteasome inhibitor, complement inhibitor, and immunoglobulin administration
Acronym
Management for antibody mediated rejection
Scientific Title
To control antibody mediated rejection following kidney and liver transplantation in ABO-incompatible, donor specific antibody positive patients by using rituximab, proteasome inhibitor, complement inhibitor, and immunoglobulin administration
Scientific Title:Acronym
Management for antibody mediated rejection
Region
| Japan |
Condition
Condition
Antibody mediated rejection
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to manage antibody mediated rejection by using rituximab (anti-CD20), proteasome inhibitor, complement inhibitor, and immunoglobulin administration in the field of kidney and liver transplantation.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Judging improvements of clinical (Cr, AST, ALT, T-Bil etc.) and pathological findings(Banff 2013 criteria) at day 1, 3, 5, 7, 14, 28, and during a follow-up period following administration.
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 375mg/m2 before (prophylaxis) or after surgery (treatment), Proteasome inhibitors 1.3mg/m2 at a time of confirming antibody mediated rejection following surgery, complement inhibitors (eculizmab) 1200 mg/day at a time of confirming antibody mediated rejection following surgery, or Intravenous immunoglobuline administration 4 mg/kg/day at a time of confirming antibody mediated rejection following surgery
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
Organ transplantation recipients who are treated in our hospital
Key exclusion criteria
Cases who has allergic reaction against relevant drugs.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Ushigome |
Organization
Kyoto Prefectural University of Medicine
Division name
Organ Transplantation and Regenerative Surgery
Zip code
6028566
Address
Kajii-cho 465, Kamigyoku, Kyoto
TEL
81752515532
tsukasa@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Shumpei |
| Middle name | |
| Last name | Harada |
Organization
Kyoto Prefectural University of Medicine
Division name
Organ Transplantation and Regenerative Surgery
Zip code
6028566
Address
Kajii-cho 465, Kamigyoku, Kyoto
TEL
81752515532
Homepage URL
shumpei@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Patient's own expense
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
Kajii-cho 465, Kamigyoku, Kyoto
Tel
81752515532
shumpei@koto.kpu-m.ac.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
| 2016 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 15 | 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
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2020 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026559
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
