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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000017605
Receipt No. R000020404
Scientific Title Optimal combination of plasma filters in therapeutic double filtration plasmapheresis fo in kidney transplant recipients with higher immunological barrier
Date of disclosure of the study information 2015/05/18
Last modified on 2019/05/23

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Basic information
Public title Optimal combination of plasma filters in therapeutic double filtration plasmapheresis fo in kidney transplant recipients with higher immunological barrier
Acronym Optimal combination of plasma filters in therapeutic double filtration plasmapheresis fo in kidney transplant recipients with higher immunological barrier
Scientific Title Optimal combination of plasma filters in therapeutic double filtration plasmapheresis fo in kidney transplant recipients with higher immunological barrier
Scientific Title:Acronym Optimal combination of plasma filters in therapeutic double filtration plasmapheresis fo in kidney transplant recipients with higher immunological barrier
Region
Japan

Condition
Condition Kidney transplantation with higher immunological barrier
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the safety and efficacy in anti-donor antibody removal with novel DFPP in immunologically high risk kidney transplant recipients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess and compare with conventional plasmapheresis in terms of the efficacy and selectivity in antibody removal.
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Different type of plasmafilter (EC-50W, Asahi-Kasei Medical) which has smaller pore size than conventional type (OP-08W, Asahi-Kasei Medical) is used as primary filter to preserve serum fibrinogen in the novel DFPP in the current study.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. kidney transplant recipients 15 y.o. or higher.
2. Immunological high risk recipients such as ABO-blood type incompatible or anti-donor-HLA antibody positive those who require pre-transplant antibody removal.
3. recipients who have sufficient informed consents.
Key exclusion criteria 1. kidney transplant candidates who experienced any unpredictable adverse events.
2. those recipients who don't have informed consents.
3. Those recipients whom the principal investigator judged as inappropriate candidates for the study.
Target sample size 13

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daiki Iwami
Organization Hokkaido University Hospital
Division name Department of Renal and Urologic Surgery
Zip code
Address North15 West7, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5966
Email iwamidaiki@ybb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daiki Iwami
Organization Hokkaido University Graduate School of Medicine
Division name Department of Renal and Genitourinary surgery
Zip code
Address North15 West7, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5966
Homepage URL
Email iwamidaiki@ybb.ne.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
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
2015 Year 05 Month 18 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
2015 Year 04 Month 02 Day
Date of IRB
2015 Year 06 Month 05 Day
Anticipated trial start date
2015 Year 06 Month 05 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 18 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020404

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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