UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051610 |
|---|---|
| Receipt number | R000058889 |
| Scientific Title | A cross-sectional multicenter,open-label,uncontrolled Examination of Peritoneal Dialysis Endoscopy for Outpatient on chronic Peritoneal dialysis. |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2024/01/15 15:23:53 |
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Basic information
Public title
Examination of Peritoneal Dialysis Endoscopy for Outpatient on chronic Peritoneal dialysis: A cross-sectional multicenter,open-label,uncontrolled Study.
Acronym
PD endoscopy study
Scientific Title
A cross-sectional multicenter,open-label,uncontrolled Examination of Peritoneal Dialysis Endoscopy for Outpatient on chronic Peritoneal dialysis.
Scientific Title:Acronym
TORCH project
Region
| Japan |
Condition
Condition
Out-clinic patients on chronic peritoneal dialysis therapy
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to evaluate the macroscopic findings of peritoneal membrane surface in patients on chronic peritoneal dialysis therapy according to the definition which is proposed from Japanese Society for Peritoneal Dialysis, and to examine the relationships between those findings and patients' clinical characteristics.
Basic objectives2
Others
Basic objectives -Others
To examine the presence of early signs of encapsulating peritoneal sclerosis, such as, neo-membrane formation, fibrin exudate, and adhesion of peritoneal membrane.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
not available
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients on peritoneal dialysys therapy in out-patient clinics
2) Patients more than 18 years old when informed consent is obtained
3) Patients on peritonea dialysis more than 3 months when informed consent is obtained
4) Patients free of catheter-related infection diseases within the past 3 months when informed consent is obtained
5) Patients who can give informed consent by oneself
Key exclusion criteria
1) Patients with active cancer
2) Patients with active infectious disease
3) Pregnant patients or patients on possible pregnancy
4) patients who are judged not applicable by investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | N/A |
| Last name | Nakayama |
Organization
St Luke's International Hospital
Division name
Division of Nephrology
Zip code
104-8560
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
0335415151
nakayama@luke.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | N/A |
| Last name | Nakayama |
Organization
St Luke's International Hospital
Division name
Division of Nephrology
Zip code
104-8560
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
0335415151
Homepage URL
nakayama@luke.ac.jp
Sponsor or person
Institute
St Luke's International Hospital
Institute
Department
Personal name
Masaaki Nakayama
Funding Source
Organization
Baxter International Inc.(USA)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St Luke's International Hospital
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
Tel
0335415151
nakayama@luke.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
23-RC017
Org. issuing International ID_1
St Luke's International Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Joint Research Institute:
Tokyo Jikei University School of Medicine, Jikei University Hospital
Tokyo Jikei University School of Medicine, Katsushika Medical Center
Tokyo University, School of Medicine, The University of Tokyo Hospital
Juntendo University, Juntendo University Hospital
Juntendo University, Juntendo University Nerima Hospital
Management information
Registered date
| 2023 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058889
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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