UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018902 |
|---|---|
| Receipt number | R000017878 |
| Scientific Title | Fukuoka Peritoneal Dialysis Database Study |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2024/01/18 13:37:34 |
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Basic information
Public title
Fukuoka Peritoneal Dialysis Database Study
Acronym
Fukuoka Peritoneal Dialysis Database Study
Scientific Title
Fukuoka Peritoneal Dialysis Database Study
Scientific Title:Acronym
Fukuoka Peritoneal Dialysis Database Study
Region
| Japan |
Condition
Condition
end-stage renal disease
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create the database system of CKD patients on peritoneal dialysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Survival time
2. Technical survival time of PD.
Key secondary outcomes
1. Residual renal function
2. Incidence rate of complications; cerebro- and cardio-vascular complications, peritonitis, exit site infection, EPS, fracture, inguinal hernia, Pleuroperitoneal communication
3. Performance status
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All of the patients with end-stage renal disease on peritoneal dialysis, who are over 15 years old, at Kyushu University Hospital and related facilities
Key exclusion criteria
not available
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Tsuruya |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5843
tsuruya@intmed2.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Yamada |
Organization
Kyushu University Hospital
Division name
Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukouka, Japan
TEL
092-642-5842
Homepage URL
ana65641@nifty.com
Sponsor or person
Institute
Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
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
Address
Tel
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
飯塚病院（福岡県），掖済会門司病院（福岡県），唐津赤十字病院（佐賀県），JCHO九州病院（福岡県），九州中央病院（福岡県），小倉記念病院（福岡県），小倉第一病院（福岡県），国立病院機構九州医療センター（福岡県），製鉄記念八幡病院（福岡県），聖マリア病院（福岡県），田川市立病院（福岡県），白十字病院（福岡県），浜の町病院（福岡県），原三信病院（福岡県），福岡赤十字病院（福岡県），益田内科クリニック（福岡県），宗像医師会病院（福岡県），門司港腎クリニック（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will register chronic kidney disease patients on peritoneal dialysis followed in Kyushu University-related facilities prospectively and retrospectively, and investigate risk factors associated with prognosis.
Management information
Registered date
| 2015 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017878
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
