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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023064
Receipt No. 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

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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
Email 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
Email shumpei@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026559

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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