UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012830 |
|---|---|
| Receipt number | R000014638 |
| Scientific Title | The high-dose intravenous immunoglobulin administration examination for high sensitization renal transplantation candidates. |
| Date of disclosure of the study information | 2014/01/14 |
| Last modified on | 2019/01/17 20:30:25 |
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Basic information
Public title
The high-dose intravenous immunoglobulin administration examination for high sensitization renal transplantation candidates.
Acronym
high dose IVIg for high sensitized renal transplantation.
Scientific Title
The high-dose intravenous immunoglobulin administration examination for high sensitization renal transplantation candidates.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yuki Miyauchi |
Organization
Ehime University
Division name
department of Urology
Zip code
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5356
uroyuukictb12@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toxhiro Nakatsuka |
Organization
Ehime University
Division name
Medical department research partnership division
Zip code
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5172
Homepage URL
rinri@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 25 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014638
