UMIN-CTR Clinical Trial

Basic information
Public title	A Phased Desensitization Protocol With Rituximab and Bortezomib for Highly HLA-sensitized Transplant Patients.
Acronym	A Phased Desensitization Protocol for DSA-positive Patients.
Scientific Title	A Phased Desensitization Protocol With Rituximab and Bortezomib for Highly HLA-sensitized Transplant Patients.
Scientific Title:Acronym	A Phased Desensitization Protocol for DSA-positive Patients.
Region	Japan

Condition
Condition	DSA-positive Transplant Patients
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clinical trial to evaluate efficacy and safety of Rituximab and Bortezomib applied to pre-operative desensitization for prevention or post-operational treatment of antibody-mediated rejection in high risk anti-HLA antibody positive organ transplantation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Negative conversion rate of cross-match test
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	First, a single dose of rituximab (375 mg/m2 body surface) was administered to the patients. And then, one cycle of bortezomib (1.3 mg/m2, days 1, 4, 8 and 11) was administered to the 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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	DSA positive patients with MFI values greater than 3,000 by LABScreen Single Antigen test. Patients who are informed of this study and consent to participate it by writing.
Key exclusion criteria	Patients with current or recent severe systemic infections requiring treatment (systemic antibiotics, antivirals, or antifungals). Serious diarrhea, active ulcer or uncontrolled diabetes likely to interfere with participation in this clinical study. Serious medical or psychiatric illness likely to interfere with participation in this clinical study. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Known history of allergy to rituximab or bortezomib. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Female subject is pregnant or breast-feeding. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideki Ohdan
Organization	Hiroshima University Hospital
Division name	Trasnplantation Surgery
Zip code
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-5222
Email	hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kentaro Ide
Organization	Hiroshima University Hospital
Division name	Trasnplantation Surgery
Zip code
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-5222
Homepage URL
Email	ideken@hiroshima-u.ac.jp

Sponsor
Institute	Transplantation Surgery, Hiroshima University Hospital
Institute
Department

Funding Source
Organization	Hiroshima University Hosital
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
Address
Tel
Email

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	2013 Year 09 Month 30 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	Suspended
Date of protocol fixation	2010 Year 03 Month 24 Day
Date of IRB	2010 Year 03 Month 24 Day
Anticipated trial start date	2010 Year 03 Month 25 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2013 Year 09 Month 30 Day
Last modified on	2020 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013914

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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