UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017605
Receipt number 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 10:29:38

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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 or person

Institute

Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



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

Value
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