UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062387 |
|---|---|
| Receipt number | R000071398 |
| 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 | 2026/09/08 |
| Last modified on | 2026/09/07 17:06:42 |
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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
Safety : Accuracy of fluid removal
Efficacy : 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
| 18 | 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 18 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 | Takuji |
| Middle name | |
| Last name | Sato |
Organization
Toray Medical Company Limited
Division name
Technology & Development Division
Zip code
4100001
Address
405-65, Ashitaka, Numazu-shi, Shizuoka, Japan
TEL
+81-55-925-5310
takuji.sato.u2@mail.toray
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Otsuka |
Organization
Toray Medical Company Limited
Division name
2nd Development Sec. Medical Device Development Dept. Technology & Development Division
Zip code
4100001
Address
405-65, Ashitaka, Numazu-shi, Shizuoka, Japan
TEL
+81-55-925-5310
Homepage URL
takuya.ootsuka.g6@mail.toray
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
MINS Clinical Research Center (NPO)
Address
1-15-14, Dogenzaka, Shibuya-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2026 | Year | 09 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate the clinical safety and efficacy of Central Dialysis fluid Delivery System (CDDS).
Management information
Registered date
| 2026 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071398
