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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032113
Receipt No. R000036634
Scientific Title Desensitization with rituximab for preformed anti-donor antibody and antibody-mediated rejection in kidney transplantation.
Date of disclosure of the study information 2018/04/05
Last modified on 2019/04/09

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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
Anticipated trial start date
2008 Year 05 Month 14 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 04 Month 05 Day
Last modified on
2019 Year 04 Month 09 Day


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

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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