UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for development of new treatment for antibody mediated rejection in organ transplantation
Title of the study (Brief title)	Development of new treatment for antibody mediated rejection
Region	Japan

Condition
Condition	organ failure
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To avoid or to treat antibody mediated rejection through depletion of B cells by anti CD20 antibody
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of diminishment of HLA antibody in desensitization changes of clinico-pathological findings in treatment
Key secondary outcomes	Change of HLA antibody titers incidence of AMR incidence of ACR patient and graft survival organ functions adverse 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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration with rituximab 375 mg/m2 once or twice
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	Patients with preoperative sensitization or with AMR Patients treated in registered institutions Patients eating or after organ transplantation (liver, heart, lung, pancreas, islet cells, small bowel) Patients who wish to participate this study for him/herself or whose gardens or representatives.
Key exclusion criteria	Patients with active infections, or malignancy, or patients whom the responsible person decided to be not appropriate.
Target sample size	41

Research contact person
Name of lead principal investigator	Hiroto Egawa
Organization	Tokyo Women's Medical University
Division name	Department of Surgery
Address	8-1 Shinjuku-ku, Kawada-cho, Tokyo
TEL	03-3353-8111
Email	egawa.hiroto@twmu.ac.jp

Public contact
Name of contact person	Hiroto Egawa
Organization	Tokyo Women's Medical University
Division name	Department of Surgery
Address	8-1 Shinjuku-ku, Kawada-cho, Tokyo
TEL	03-3353-8111
Homepage URL
Email	egawa.hiroto@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 01 Month 09 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 22 Day
Last modified on	2018 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034846