UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038181
Receipt number 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 2023/10/31 16:49:49

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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 or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



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

13

Results

16 cases of diseased kidney transplantation were peformed after machine perfusion preservation.

Donor age;21~65y/o. Recopient age: 37~66y/o. Donor Cr before procurement: 0.47~4.1mg/dl Machine eprfusion time: 85~250min.
All kidney was perfused without any troubles, and not required post.op HD until discharge.

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); 4 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

Japan Society for clinical renal tarsnplantation Sep/2021
Japanese society for Organ Transplantation, Machine perfusion meeting ( Sep/2021)
Japanese Society for Organ preservation and Biology2021 Key Note (Nov.2021)
Spring Seminar , Japanese Society for organ transplantation (March/2022
H.Iwamoto et al;Japanese scoety ofr organ transplantation 2022


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

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 03 Month 31 Day

Date analysis concluded

2025 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2019 Year 10 Month 02 Day

Last modified on

2023 Year 10 Month 31 Day



Link to view the page

Value
https://center6.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