UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056690 |
|---|---|
| Receipt number | R000064797 |
| Scientific Title | Follow-up observation of peritoneal membrane in patients on peritoneal dialysis |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/01/12 09:09:44 |
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Basic information
Public title
Study of peritoneal membrane in patients on peritoneal dialysis
Acronym
Torch study
Scientific Title
Follow-up observation of peritoneal membrane in patients on peritoneal dialysis
Scientific Title:Acronym
Torch study
Region
| Japan |
Condition
Condition
end-stage kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe macroscopic findings of peritoneal membrane in patients on peritoneal dialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine the macroscopic findings of peritoneal membrane in patients on peritoneal dialysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
obsservation of peritoneal membrane by ultr-fine endoscope
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
This study targets 60 cases of outpatient peritoneal dialysis (PD) patients (including those undergoing hemodialysis) who underwent endoscopic examination of the relevant equipment in 2024 and meet the following criteria a) to d):
a) Patients aged 18 years or older at the time of obtaining consent (met).
b) Patients who have been on PD for at least three months at the time of obtaining consent (met).
c) Patients who do not have catheter-related peritonitis at the time of obtaining consent.
d) Patients who, after receiving a thorough explanation of the study and gaining a sufficient understanding, provided written consent to participate of their own free will.
Key exclusion criteria
1) Patients who have discontinued peritoneal dialysis.
2) Patients with coexisting malignant tumors requiring treatment.
3) Patients with coexisting highly active infections.
4) Women who are pregnant or may be pregnant.
5) Other cases deemed inappropriate by the principal investigator (or co-investigators).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | MASAAKI |
| Middle name | |
| Last name | NAKAYAMA |
Organization
St Luke's International University
Division name
Division of Research management
Zip code
1048560
Address
Akshicho 9-1, Chuo-ku, Tokyo
TEL
0335415151
nakayama@luke.ac.jp
Public contact
Name of contact person
| 1st name | MASAAKI |
| Middle name | |
| Last name | NAKAYAMA |
Organization
Torch study group
Division name
head office Nakayama Laboratory
Zip code
1040045
Address
Tsukiji 3-8-5, Chuo-ku, Tokyo
TEL
03-6226-6361
Homepage URL
nakayama@luke.ac.jp
Sponsor or person
Institute
St Luke's International University
Institute
Department
Personal name
Funding Source
Organization
Baxter International Inc.
Organization
Division
Category of Funding Organization
Other
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
Akashicho 9-1, Chuo-ku, Tokyo
Tel
03-3541-5151
nakayama@luke.ac.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 | 05 | 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
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 12 | Day |
Last modified on
| 2025 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064797
