UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035491 |
|---|---|
| Receipt number | R000040297 |
| Scientific Title | Comparison of the General condition between Peritoneal Dialysis snd Hemodialysis in Latter-Stage Elderly Patients |
| Date of disclosure of the study information | 2019/01/15 |
| Last modified on | 2024/01/12 12:42:01 |
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Basic information
Public title
Comparison of the General condition between Peritoneal Dialysis snd Hemodialysis in Latter-Stage Elderly Patients
Acronym
Comparison of the General condition between Peritoneal Dialysis snd Hemodialysis in Latter-Stage Elderly Patients
Scientific Title
Comparison of the General condition between Peritoneal Dialysis snd Hemodialysis in Latter-Stage Elderly Patients
Scientific Title:Acronym
Comparison of the General condition between Peritoneal Dialysis snd Hemodialysis in Latter-Stage Elderly Patients
Region
| Japan |
Condition
Condition
End-stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In latter -stage elderly patients undergoing dialysis, to maintain the general condition is important in order to keep the QOL and prognosis.Therefore, it is considered that to compare the general codition using Bathel Index(BI) and Karnofsky Performance Status(KPS) is clinically worthwhile for patients with both hemodialysis and peritoneal dialysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of both BI and KPS every 3 months for 2 years
Key secondary outcomes
1)Change of HDS-R every 6 month for 2 years
2)Change of Zarit Burden Interview(ZBI) every 6 month for 2 years based on presence or absence of visiting nursing
3)Monitoring of laboratory date every 3 months for 2 years
4)Death and cause of death
5)Hospital readmission, cause of rehospitalization, duration of rehospitalization, date and time in the termination of PD/HD, reason for termination of HD/PD
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients newly introduced to HD or PD
2)Patients who are 75 years or older, without regard to sex
3)Patients who chose renal replacement therapy by SDM(shared decision making)
4)Patients who are anticipated to have stable symptoms during hospitalization
5)Patients who have signed written informed consent for this study
Key exclusion criteria
1)Patients who prognosis is within 5 years and have clinically important complications, including malignant tumors or others
2)Patients who have malignant tumors while being treated with a carcinostatic agent or radiation therapy
3)Patients who are expected to progressively worsen in their general condition due to the progression of complications
4)Patients who are deemed to have a considerably low cognitive ability
5)Patients with already markedly poor general condition at introduction time
6)Patients judged unsuitable for inclusion by the investigator
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Yoshihara |
Organization
Hakodate Goryoukaku Hospital
Division name
nephrology
Zip code
040-8611
Address
38-3 Goryoukaku Hakodate
TEL
0138-51-2295
ryojiharunatsu@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Yoshihara |
Organization
Hakodate Goryoukaku Hospital
Division name
nephrology
Zip code
040-8611
Address
38-3 Goryoukaku Hakodate
TEL
0138-51-2295
Homepage URL
ryojiharunatsu@yahoo.co.jp
Sponsor or person
Institute
Hakodate Goryoukaku Hospital
Institute
Department
Personal name
Funding Source
Organization
Hakodate Goryoukaku Hospital
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
Hakodate Goryoukaku Hospital institutional review board
Address
38-3 Goryoukaku Hakodate
Tel
0138-51-2295
s-sato@gobyou.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
函館五稜郭病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.jsdt.or.jp/
Publication of results
Published
Result
URL related to results and publications
https://www.jsdt.or.jp/
Number of participants that the trial has enrolled
38
Results
The HD group showed significant improvement in ADL after the start of dialysis. The PD group was older than the HD group, but there was no difference in cognitive decline or time to discontinuation of observation compared to the HD group.
Results date posted
| 2024 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Newly diagnosed HD or PD patients over 75 years old
Participant flow
Barcell index and KPS were measured every 3 months and HDS-R every 6 months for 2 years
Adverse events
none
Outcome measures
The primary endpoint was the change in Barcell index and KPS every 3 months for 2 years, and the secondary endpoints were the change in HDS-R every 6 months for 2 years and the time until discontinuation of observation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 09 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 09 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 09 | Day |
Other
Other related information
1)Change of both BI and KPS every 3 months for 2 years
2)Change of HDS-R every 6 month for 2 years
3)Change of Zarit Burden Interview(ZBI) every 6 month for 2 years based on presence or absence of visiting nursing
4)Monitoring of laboratory date every 3 months for 2 years
5)Death and cause of death
5)Hospital readmission, cause of rehospitalization, duration of rehospitalization, date and time in the termination of PD/HD, reason for termination of HD/PD
The above particulars are observated and assessed in patients newly introduced to HD or PD.
Management information
Registered date
| 2019 | Year | 01 | Month | 08 | Day |
Last modified on
| 2024 | 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=R000040297
