UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027140
Receipt number R000031100
Scientific Title Clinical evaluation of the performance and safety on hollow fiber type dialyzer "APS-MA".
Date of disclosure of the study information 2017/04/28
Last modified on 2018/03/22 16:54:27

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Basic information

Public title

Clinical evaluation of the performance and safety on hollow fiber type dialyzer "APS-MA".

Acronym

Clinical evaluation of APS-MA

Scientific Title

Clinical evaluation of the performance and safety on hollow fiber type dialyzer "APS-MA".

Scientific Title:Acronym

Clinical evaluation of APS-MA

Region

Japan


Condition

Condition

Chronic Kidney Failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the performance, blood compatibility and safety of APS-21MA compared with APS-21MDNew.

Basic objectives2

Others

Basic objectives -Others

Peformance, Safety

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Clearance
2) Reduction rate
3) Removal amount
4) Albumin leakage
5) Blood compatibility (Fluctuations in the number of white blood cells and platelets during hemodialysis)
6) Antithrombotic property

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Hemodialysis using APS-MA and APS-MDNew for 2 weeks each

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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Maintenance dialysis patients corresponding to
- three times per week
- more than three and a half hours in each dialysis session
- hemodialysis for more than six months
2)Qb 200 mL/min is possible when the evaluation.
3)Outpatients.
4)Ability to give written informed consent.
5)Aged 20 to <80 years at the time of informed consent.

Key exclusion criteria

1)Need to blood purification other than hemodialysis.
2)Judged ineligible by the attending physician.

Target sample size

6


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiko Nakajima

Organization

Rokko Island Konan Hospital

Division name

Blood purification Center

Zip code


Address

2-11 Koyo-cho Naka, Higashinada-ku, Kobe

TEL

078-858-1111

Email

ro_jinkoujinzoubu@kohnan.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroko Haibara

Organization

Rokko Island Konan Hospital

Division name

Medical Engineering Center

Zip code


Address

2-11 Koyo-cho Naka, Higashinada-ku, Kobe

TEL

078-858-1111

Homepage URL


Email

ro_jinkoujinzoubu@kohnan.or.jp


Sponsor or person

Institute

Rokko Island Konan Hospital

Institute

Department

Personal name



Funding Source

Organization

ASAHI KASEI MEDICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

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

2017 Year 04 Month 28 Day


Related information

URL releasing protocol


Publication of results

Published


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

2017 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2017 Year 05 Month 08 Day

Last follow-up date

2017 Year 07 Month 08 Day

Date of closure to data entry

2017 Year 07 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 04 Month 26 Day

Last modified on

2018 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031100


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name