UMIN-CTR Clinical Trial

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
Institute	Toray Medical Company Limited
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045770