UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038405 |
|---|---|
| Receipt number | R000043767 |
| Scientific Title | the relationship between physical function and adverse event in elderly patients undergoing peritoneal dialysis: a prospective cohort study. |
| Date of disclosure of the study information | 2019/10/29 |
| Last modified on | 2022/05/06 11:28:53 |
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Basic information
Public title
the relationship between physical function and adverse event in elderly patients undergoing peritoneal dialysis: a prospective cohort study.
Acronym
the relationship between physical function and adverse event in elderly patients undergoing peritoneal dialysis: a prospective cohort study.
Scientific Title
the relationship between physical function and adverse event in elderly patients undergoing peritoneal dialysis: a prospective cohort study.
Scientific Title:Acronym
the relationship between physical function and adverse event in elderly patients undergoing peritoneal dialysis: a prospective cohort study.
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to assess the physical function in elderly PD patients and investigate association between physical function and prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall mortality
Key secondary outcomes
Cardiovascular event, peritonitis, hospitalization, Withdrawal of peritoneal dialysis
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients undergoing peritoneal dialysis
Patients with written informed consent after receiving a full explanation
Patients without apparent dementia
Key exclusion criteria
patient with hemodialysis
patient with renal transplant
Patient judged to be inappropriate by the charge doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yabe |
Organization
Seirei christopher university
Division name
Department of Rehabilitation
Zip code
433-8558
Address
3453 Mikatahara, Kita-ku, Hamamatsu, Shizuoka.
TEL
0534391400
yabe0909@gmail.com
Public contact
Name of contact person
| 1st name | Yabe |
| Middle name | |
| Last name | Hiroki |
Organization
Seirei christopher university
Division name
Department of Rehabilitation
Zip code
433-8558
Address
3453 Mikatahara, Kita-ku, Hamamatsu, Shizuoka.
TEL
0534391400
Homepage URL
yabe0909@gmail.com
Sponsor or person
Institute
Nagoya Kyoritsu Hospital
Institute
Department
Personal name
Funding Source
Organization
japan society for the promoting of science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya Kyoritsu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Christopher University
Address
3453 Mikatahara, kita-ku Hamamatsu, Shizuoka
Tel
0534391400
yabe0909@gmail.com
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
名古屋共立病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 30 | Day |
Other
Other related information
observation of adverse events in regular outpatient clinics
Management information
Registered date
| 2019 | Year | 10 | Month | 28 | Day |
Last modified on
| 2022 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043767
