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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038181
Receipt No. R000043379
Scientific Title The efficacy and safety of machine perfusion preservation for marginal kidney graft
Date of disclosure of the study information 2020/04/01
Last modified on 2021/10/19

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Basic information
Public title The efficacy and safety of machine perfusion preservation for marginal kidney
Acronym The efficacy and safety of machine perfusion preservation for marginal kidney graft
Scientific Title The efficacy and safety of machine perfusion preservation for marginal kidney graft
Scientific Title:Acronym The efficacy and safety of machine perfusion preservation for marginal kidney graft
Region
Japan

Condition
Condition End stage renal disease
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The safety and efficacy of machine perfusion preservation for marginal kidney transplantation grafts
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Major endopoints
The stability of flow, perfusion pressure and temparature during perfusion preservation for two hours
Key secondary outcomes Post op. HD days, Frequency of required post op HD
Post op Cr(mg/dl)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Kidney for transplantation procured from marginal donor graft is preserved by machine perfusion system.
Kidney is preserved after procurement by simple storage in donor hospital ,then, transfered and perfused for 2 hours in a hypothermic state under 30mmHg of renal arterial pressure in recipient hosipital
.Perfusion time will be at least 2 hours
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
70 years-old >=
Gender Male and Female
Key inclusion criteria kidney graft is selected by Japanese Organ Transolant Network
Among kidney graft,
marginal donor graft is used for this study under the criteria of United Nation Organ Sharing in USA
1)Donor age morethan 60Y/O
2)Donor age morethan 50y/o and death b cerebro-cardiavascular disease, hypertension or serum Cr more than 1.5 mg/dl
3) Death after cardiac death donor
Key exclusion criteria Exclusion criteria
1;Disease
1) Severe heart, liver disease
2) Active infection
3) Malignant disease
4) Others by professional judgement by Medical Dr
2) Female; Pregnant male; having baby until 3 months after transplantation
3) Under 18 Y/oat the time of transplantation
4) Simutaneous pancreas and kidney transplantation
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Naoto
Middle name
Last name Matsuno
Organization Asahikawa Medical University
Division name Hepato-Biliary- Pancreas surgery & Transplantation
Zip code 078-8510
Address Midorigaoka Higashi 2-1, Asahikawa, Hokkaido, Japan
TEL 0166-68-2508
Email mtn@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name Naoto
Middle name
Last name Matsuno
Organization Asahikawa Medical Unievrsity
Division name Hepato-Biliary- Pancreas surgery & Transplantation
Zip code 078-8510
Address Midorigaoka Higashi 2-1, Asahikawa, Hokkaido, Japan
TEL 0166(68)2508
Homepage URL
Email mtn@ashiakwa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Self fiunding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo medical university hachioji medical center
Toranomon hospital
Tohoku university
Fujita health university
Asahikawa medical university
Name of secondary funder(s)

IRB Contact (For public release)
Organization Asahikawa Medical University
Address Midorigaoka Higashi 2-1, Asahikawa , HOkkaido,
Tel 0166-68-2508
Email mtn@asahikawa-med.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 東京医科大学八王子医療センター(東京都)、虎の門病院(東京都)、東北大学病院(宮城県)、藤田医科大学病院(愛知県)、旭川医科大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 7
Results 5 cases of diseased kidney transplantation were peformed after machine perfusion preservation. All kidney was perfused without any troubles, and not required post.op HD untill dischrge.
Results date posted
2021 Year 03 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 03 Month 18 Day
Baseline Characteristics Donor age54~65 y/o
Recipient age; 47~66 y/o
Years of pre.op HD: 13~24
DCD(Donation after cardiac death); 2 cases
Participant flow Warm isdhemic time :0~18 min.
total ischemic time 7:10~15;27
Adverse events ascites 1 case.
No trouble related with machine perfusion preservation
Outcome measures Renal function after transplantation
Days required HD; 0 day om 3cases, 8 days in 1 case, 18 days in 1 case
All cases was no HD at the time of
discharge.
Best Cr after transplantation were 1,71,1,60,1,19,1,10,1,81(mg/dl) in each case.
Plan to share IPD Yes
IPD sharing Plan description Original article
Y Nakamura et al Transplantation proc.2021
S Miyagi et al : Ishoku (in Japanes) 20211

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 11 Month 01 Day
Date of IRB
2020 Year 09 Month 10 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2023 Year 03 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
2019 Year 10 Month 02 Day
Last modified on
2021 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043379

Research Plan
Registered date File name
2021/04/13 研究計画書 20190912.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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