UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003659 |
|---|---|
| Receipt number | R000004432 |
| Scientific Title | Peritoneal Dialysis Registry-Cohort Study |
| Date of disclosure of the study information | 2010/05/24 |
| Last modified on | 2024/08/26 15:54:57 |
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Basic information
Public title
Peritoneal Dialysis Registry-Cohort Study
Acronym
PDR-CS
Scientific Title
Peritoneal Dialysis Registry-Cohort Study
Scientific Title:Acronym
PDR-CS
Region
| Japan |
Condition
Condition
Chronic renal failure (Peritoneal dialysis)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is:
1) To establish internet-based registry systems in Japanese patients receiving PD
2) To identify predictors to preserve residual renal function among diabetic or elderly patients undergoing PD in a multi-center, prospective, observational study
Basic objectives2
Others
Basic objectives -Others
Prospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Predictors to preserve residual renal function in diabetic PD and elderly PD patients
2) Incidence of peritonitis
3) Technique survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing peritoneal dialysis in university hospitals and affiliate hospitals
Key exclusion criteria
No one particular
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Sugiyama |
Organization
Okayama University Graduate School
Division name
Center for chronic kidney disease and peritoneal dialysis
Zip code
7008558
Address
Shikata-cho 2-5-1, Okayama, Japan
TEL
086-235-7235
hitoshis@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Sugiyama |
Organization
Okayama University Graduate School
Division name
Center for chronic kidney disease and peritoneal dialysis
Zip code
7008558
Address
2-5-1 Shikatacho Kitaku, Okayama, Japan
TEL
086-235-7235
Homepage URL
hitoshis@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School
Center for chronic kidney disease and peritoneal dialysisyama University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee of Okayama University
Address
2-5-1 Shikatacho, Kita-ku, Okayama 700-8558, Japan
Tel
0862357235
hitoshis@okayama-u.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
岡山大学病院、名古屋大学病院、九州大学病院、新潟大学病院、長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
250
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
| 2009 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2009 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Past history, peripheral blood, blood chemistry, CTR, peritoneal mesothelial cytology, peritonitis, exit-site infection, peritoneal equilibration test, Kt/V (total, renal, peritoneal)
Management information
Registered date
| 2010 | Year | 05 | Month | 24 | Day |
Last modified on
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004432
