UMIN-CTR Clinical Trial

Basic information
Public title	Desensitization therapy for preexisted anti-HLA antibody with anti-CD20 Antibody, plasma exchange, and immunoglobulin in kidney transplantation
Acronym	desensitization therapy for preexisted anti-HLA antibody
Scientific Title	Desensitization therapy for preexisted anti-HLA antibody with anti-CD20 Antibody, plasma exchange, and immunoglobulin in kidney transplantation
Scientific Title:Acronym	desensitization therapy for preexisted anti-HLA antibody
Region	Japan

Condition
Condition	kidney transplantation recipients with preexisted anti-HLA antibody
Classification by specialty	Nephrology Urology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm a safety of desensitization therapy, including rituximab administration, for kidney transplantation recipients with HLA-Donor specific antibody positive.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	graft failure rate
Key secondary outcomes	patient survival rate rate of allograft rejection adverse effect rate

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	Rituximab administration single dose administration of 200mg/body before renal transplantation Plasma exchange three to four times replaced by albumin Immunoglobulin administration IVIG 2-3g/kg when donor specific antibody is high MFI (>3000)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Kidney transplantation recipients with HLA-donor specific antibody at Division of Nephrology and hypertension, department of internal medicine, and Urology, The Jikei University of Medicine. 2)The patient who can have a decision about the participation of this study voluntary, and understand consent brief and other explanation documents.
Key exclusion criteria	1) The patients with serious hypersensitivity or medical history of anaphylaxis for the products derived from mouse protein, Rituximab, immunoglobulin, and an integrent of the albumin to prepare plasma exchange. 2) The patients whom the medical attendant judged when the exacerbation of the sign exceeded benefit of Rituximab among them who have severe infectious diseases, a cardiac dysfunction, respiratory diseases, or a bone marrow dysfunction. 3) The patients with an medical history of the drug hypersensitivity and the allergic to albumin (preparation for plasma exchange), Rituximab or immunoglobulin whom the medical attendant judged when these adverse effects exceeded the benefits of these medications.
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Yokoo
Organization	The Jikei University of Medicine
Division name	Division of Nephrology and Hypertension, Department of Internal Medicine
Zip code	105-8461
Address	Minato-ku, Tokyo
TEL	+81-3-3433-1111
Email	nakadaya@jikei.ac.jp

Public contact
Name of contact person	1st name Yasuyuki Middle name Last name Nakada
Organization	The Jikei University of Medicine
Division name	Division of Nephrology and Hypertension, Department of Internal Medicine
Zip code	105-8461
Address	3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo
TEL	+81-3-3433-1111
Homepage URL
Email	tyokoo@jikei.ac.jp

Sponsor
Institute	Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University of Medicine
Institute
Department

Funding Source
Organization	Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Division of Hypertension and Nephrology, Department of Internal Medicine, The Jikei University School of Medicine
Address	3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
Tel	+81334331111
Email	nakadaya@jikei.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	2016 Year 02 Month 01 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	2016 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date	2016 Year 01 Month 27 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	2016 Year 02 Month 01 Day
Last modified on	2019 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022370