UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039638 |
|---|---|
| Receipt number | R000045204 |
| Scientific Title | Relationship between constipation and quality of life in prevalent peritoneal dialysis patients |
| Date of disclosure of the study information | 2020/02/28 |
| Last modified on | 2020/02/28 19:54:01 |
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Basic information
Public title
Relationship between constipation and quality of life in prevalent peritoneal dialysis patients
Acronym
PD and constipation
Scientific Title
Relationship between constipation and quality of life in prevalent peritoneal dialysis patients
Scientific Title:Acronym
PD and constipation
Region
| Japan |
Condition
Condition
CKDG5D(peritoneal dialysis)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the prevalence of constipation and QOL
Basic objectives2
Others
Basic objectives -Others
QOL (japanese SF-36v2; Medical Outcome Trust, QualityMetric Inc., Fukuhara S)
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL score
Key secondary outcomes
morbidity of constipation, laxatives prescription ratio, peritonitis rate, technical survival of PD, survival, hospitalization ratio
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
outpatients on peritoneal dialysis
Key exclusion criteria
none
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nanae |
| Middle name | |
| Last name | Matsuo |
Organization
The Jikei University School of Medicine
Division name
Nephrology and Hypertension
Zip code
105-8471
Address
3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
TEL
0334331111
nana77m@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Nanae |
| Middle name | |
| Last name | Matsuo |
Organization
The Jikei University School of Medicine
Division name
Nephrology and Hypertension
Zip code
105-8471
Address
3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
TEL
0334331111
Homepage URL
nana77m@jikei.ac.jp
Sponsor or person
Institute
Division of Nephrology and Hypertension, Departmant of Internal Medicine, The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Clinical Research Support Center, The Jikei University School of Medicine
Address
3-25-8, Nishi-shimbashi, Minato-ku, Tokyo
Tel
0334331111
clresuce@jikei.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
東京慈恵会医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 28 | 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
| 2019 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
peritonitis, technical survival of PD, survival, hospitalization
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045204
