UMIN-CTR Clinical Trial

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