UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040141
Receipt number R000045770
Scientific Title A multi-institutional retrospective observational study on the clinical safety and efficacy of Central Dialysis fluid Delivery System (CDDS)
Date of disclosure of the study information 2020/06/01
Last modified on 2021/03/02 09:09:45

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Basic information

Public title

A multi-institutional retrospective observational study on the clinical safety and efficacy of Central Dialysis fluid Delivery System (CDDS)

Acronym

A study on the clinical safety and efficacy of CDDS

Scientific Title

A multi-institutional retrospective observational study on the clinical safety and efficacy of Central Dialysis fluid Delivery System (CDDS)

Scientific Title:Acronym

A study on the clinical safety and efficacy of CDDS

Region

Japan


Condition

Condition

chronic renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We evaluate the clinical safety and efficacy of Central Dialysis fluid Delivery System (CDDS).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Accuracy of fluid removal
Incidence of adverse events and malfunctions

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Chronic hemodialysis patients who receive maintenance hemodialysis at a frequency of 3 times / week at the institutions during the clinical data collection period
2)Patients who are 20 years or older at the time of registration (no age-upper limit)
3)Patients who receive dialysis in modes other than ECUM (UF) during the clinical data collection period
4)Patients who undergo a routine blood test at least once a month as part of regular medical treatment during the clinical data collection period

Key exclusion criteria

1)Patients who use continuous ambulatory peritoneal dialysis (CAPD) together during the clinical data collection period
2)Patients who are judged inappropriate for inclusion in this study by the investigators

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Masamiki
Middle name
Last name Miwa

Organization

Medical corporation Kojinkai Atsuta Clinic

Division name

Director

Zip code

456-0074

Address

61-3, Hibinocho, Atsuta-ku, Nagoya-shi, Aichi

TEL

052-683-6810

Email

miwamasamiki@gmail.com


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Otsuka

Organization

Toray Medical Company Limited

Division name

Dialysis Division Technical Service Division Technical Sales Dept.

Zip code

410-0001

Address

405-65, Ashitaka, Numazu-shi, Shizuoka

TEL

055-925-5320

Homepage URL


Email

Takuya_Ootsuka@tmc.toray.co.jp


Sponsor or person

Institute

Toray Medical Company Limited

Institute

Department

Personal name



Funding Source

Organization

Toray Medical Company Limited

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

Joint Institutional Review Board

Address

1-14, Minamikubo, Kochi-shi, Kochi

Tel

042-648-5551

Email

godou-irb@epsogo.co.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



Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 01 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

120

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

2020 Year 04 Month 17 Day

Date of IRB

2020 Year 04 Month 17 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2020 Year 07 Month 31 Day

Date of closure to data entry

2020 Year 07 Month 31 Day

Date trial data considered complete

2020 Year 08 Month 28 Day

Date analysis concluded

2021 Year 01 Month 14 Day


Other

Other related information

We evaluate the clinical safety and efficacy of Central Dialysis fluid Delivery System (CDDS).


Management information

Registered date

2020 Year 04 Month 13 Day

Last modified on

2021 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045770


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name