UMIN-CTR Clinical Trial

Basic information
Public title	Desensitization with rituximab for preformed anti-donor antibody and antibody-mediated rejection in kidney transplantation.
Acronym	Desensitization with rituximab for preformed anti-donor antibody and antibody-mediated rejection in kidney transplantation.
Scientific Title	Desensitization with rituximab for preformed anti-donor antibody and antibody-mediated rejection in kidney transplantation.
Scientific Title:Acronym	Desensitization with rituximab for preformed anti-donor antibody and antibody-mediated rejection in kidney transplantation.
Region	Japan

Condition
Condition	end stage renal disease
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of pre transplant desensitization with rituximab for preformed anti-donor antibody in kidney transplant recipients and treatment for antibody-mediated rejection with rituximab in kidney transplant recipients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	value of anti-donor antibody
Key secondary outcomes	kidney graft function

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	200mg of rituximab will given twice intravenously for each patient. Rituximab will reduce to 100mg for pediatric patients.
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	10 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with preformed anti-donor antibody and/or antibody-mediated rejection
Key exclusion criteria	active infection
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Yamamoto
Organization	Hyogo College of Medicine
Division name	Kidney Transplant Center and Department of Urology
Zip code	6638501
Address	1-1 Mukogawacho, Nishinomiya, Hyogo Japan
TEL	0798-45-6366
Email	nojimam@hyo-med.ac.jp

Public contact
Name of contact person	1st name Michio Middle name Last name Nojima
Organization	Hyogo College of Medicine
Division name	Department of Urology
Zip code	6638501
Address	1-1 Mukogawacho, Nishinomiya, Hyogo Japan
TEL	0798-45-6366
Homepage URL
Email	nojimam@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
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	Hyogo College of Medicine
Address	1-1 Mukogawacho, Noshinomiya Hyogo, Japan
Tel	N/A
Email	N/A

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 05 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	Enrolling by invitation
Date of protocol fixation	2008 Year 05 Month 14 Day
Date of IRB	2008 Year 05 Month 14 Day
Anticipated trial start date	2008 Year 05 Month 14 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 05 Day
Last modified on	2020 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036634