UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058661 |
|---|---|
| Receipt number | R000067081 |
| Scientific Title | Fukuoka Red Cross hospital Peritoneal Dialysis Registry |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/31 18:56:11 |
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Basic information
Public title
Fukuoka Red Cross hospital Peritoneal Dialysis Registry
Acronym
FRC-PDR
Scientific Title
Fukuoka Red Cross hospital Peritoneal Dialysis Registry
Scientific Title:Acronym
FRC-PDR
Region
| Japan |
Condition
Condition
End-stage kidney disease on peritoneal dialysis
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop evidence related to peritoneal dialysis, including mortality and cardiovascular events, withdrawal from peritoneal dialysis, and development of infections including peritonitis and exit-site infections.
Basic objectives2
Others
Basic objectives -Others
To establish a database of peritoneal dialysis patients at Japanese Red Cross Fukuoka Hospital.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Life expectancy and cardiovascular events, withdrawal from peritoneal dialysis, and development of infections including peritonitis and exit-site infections
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
All patients receiving peritoneal dialysis therapy at our hospital or who were receiving peritoneal dialysis therapy on or after April 1, 2018 will be included.
Key exclusion criteria
(i) Cases who requested not to participate in this study based on publicly available information
(ii) Untraceable cases
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakai |
Organization
Japanese Red Cross Fukuoka Hospital
Division name
Division of Nephrology and Dialysis Center
Zip code
815-8555
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, Japan
TEL
0570-03-1211
kentaro-kyu@umin.org
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakai |
Organization
Japanese Red Cross Fukuoka Hospital
Division name
Division of Nephrology and Dialysis Center
Zip code
815-8555
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, Japan
TEL
0570-03-1211
Homepage URL
kentaro-kyu@umin.org
Sponsor or person
Institute
kentaro-kyu@umin.org
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
Japanese Red Cross Fukuoka hospital Clinical Research center
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, Japan
Tel
0570-03-1211
fukuoka-kenkyu@fukuoka-med.jrc.or.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
| 2025 | Year | 08 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2035 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study based on a registry of all peritoneal dialysis patients at Fukuoka Red Cross Hospital. Based on patient information, medical practices, and routine laboratory tests, we evaluated patient survival, peritoneal dialysis continuation and residual renal function decline, complication rates (cerebrovascular complications, arrhythmias, hernias, pleuroperitoneal communication, encapsulating peritoneal sclerosis, infections including peritonitis and exit-site infection, fractures, malignancy, and all hospitalizations), and factors affecting activities of daily living to improve the quality of peritoneal dialysis in our hospital.
Management information
Registered date
| 2025 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067081
