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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name