UMIN-CTR Clinical Trial

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
Last 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
1st 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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020404