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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018523
Receipt No. R000021440
Scientific Title Longitudinal observatinal study on patients receiving maintenance hemodialysis for more than 10 years: Impact of the onset of dialysis-related amyloidosis on QOL
Date of disclosure of the study information 2015/08/03
Last modified on 2019/08/09

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Basic information
Public title Longitudinal observatinal study on patients receiving maintenance hemodialysis for more than 10 years: Impact of the onset of dialysis-related amyloidosis on QOL
Acronym Impact of the onset of dialysis-related amyloidosis on QOL in patients on hemodialysis for more than 10 years
Scientific Title Longitudinal observatinal study on patients receiving maintenance hemodialysis for more than 10 years: Impact of the onset of dialysis-related amyloidosis on QOL
Scientific Title:Acronym Impact of the onset of dialysis-related amyloidosis on QOL in patients on hemodialysis for more than 10 years
Region
Japan

Condition
Condition Chronic kidney disease Stage 5D requiring maintenance hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the impact of dialysis-related amyloidosis on QOL in patients on hemodialysis for more than 10 years using a longitudinal observational study
Basic objectives2 Others
Basic objectives -Others Actual condition survey
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes QOL changes during the two years evaluated by the EuroQOL (EQ-5D)
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients on hemodialysis for more than 10 years
2. Patients whose age at informed consent is not less than 20 years
3. Patients with written informed consent
Key exclusion criteria 1. Patients who were re-initiated on hemodialysis after kidney transplantation
2. Patients who have no ability to respond to the questionnaire (EQ-5D)
3. Patients who are not considered to be appropriate to participate in this study
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Hirakata
Organization Fukuoka Renal Clinic
Division name Division of Nephrology
Zip code
Address 4-6-20 Watanabe-dori, Chuo-ku, Fukuoka 810-0004, Japan
TEL 092-761-4937
Email hirakata@fukuoka-renal-clinic.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Otsuka
Organization Clinical Investigational Center
Division name Kyushu Dialysis-Related Amyloidosis Study Group secretariat
Zip code
Address 3-11-4 Narusegaoka, Machida-shi, Tokyo 194-0011, Japan
TEL 042-810-2229
Homepage URL
Email otsuka@npo-cic.jp

Sponsor
Institute Kyushu Dialysis-Related Amyloidosis Study Group
Institute
Department

Funding Source
Organization KANEKA Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 03 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 Completed
Date of protocol fixation
2014 Year 12 Month 05 Day
Date of IRB
2014 Year 12 Month 05 Day
Anticipated trial start date
2015 Year 03 Month 10 Day
Last follow-up date
2016 Year 11 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a prospective observational study to evaluate the decline in QOL due to onset of DRA.

Management information
Registered date
2015 Year 08 Month 03 Day
Last modified on
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021440

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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