UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011914
Receipt number R000013914
Scientific Title A Phased Desensitization Protocol With Rituximab and Bortezomib for Highly HLA-sensitized Transplant Patients.
Date of disclosure of the study information 2013/09/30
Last modified on 2023/04/08 11:29:32

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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 Hideki
Middle name
Last name Ohdan

Organization

Hiroshima University Hospital

Division name

Trasnplantation Surgery

Zip code

7348551

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 Kentaro
Middle name
Last name Ide

Organization

Hiroshima University Hospital

Division name

Trasnplantation Surgery

Zip code

7348551

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

082-257-5222

Homepage URL


Email

ideken@hiroshima-u.ac.jp


Sponsor or person

Institute

Transplantation Surgery, Hiroshima University Hospital

Institute

Department

Personal name



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

Ethical Committee for Clinical Research of Hiroshima University

Address

1-2-3, Kasumi, Minami-ku, Hiroshima

Tel

082-257-1947

Email

iryo-seisaku@office.hiroshima-u.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

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

Enrolling by invitation

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

2023 Year 04 Month 08 Day



Link to view the page

Value
https://center6.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