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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035491
Receipt No. 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 2019/07/15

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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
Email 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
Email ryojiharunatsu@yahoo.co.jp

Sponsor
Institute Hakodate Goryoukaku Hospital
Institute
Department

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
Email 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
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 Open public recruiting
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
2019 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040297

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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