UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The high-dose intravenous immunoglobulin administration examination for high sensitization renal transplantation candidates.
Title of the study (Brief title)	high dose IVIg for high sensitized renal transplantation.
Region	Japan

Condition
Condition	high sensitized renal transplantation candidates
Classification by specialty	Nephrology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	avoiding Antibody mediated rejection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	I perform kidney biopsy after transplant in approximately three months and confirm it pathologically.
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	2-4 g/kg globulin is administrated in perioperative five days.
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	positive crossmatch high level of DSA
Key exclusion criteria	heart failure
Target sample size	10

Research contact person
Name of lead principal investigator	Yuki Miyauchi
Organization	Ehime University
Division name	department of Urology
Address	Shitsukawa, Toon, Ehime
TEL	089-960-5356
Email	uroyuukictb12@yahoo.co.jp

Public contact
Name of contact person	Toxhiro Nakatsuka
Organization	Ehime University
Division name	Medical department research partnership division
Address	Shitsukawa, Toon, Ehime
TEL	089-960-5172
Homepage URL
Email	rinri@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University
Institute
Department

Funding Source
Organization	Ehime University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2014 Year 01 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 25 Day
Anticipated trial start date	2013 Year 11 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 12 Day
Last modified on	2019 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014638