UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012686
Receipt number R000013690
Scientific Title Cross-sectional epidemiological study on patients receiving maintenance hemodialysis for more than 10 years: Research on the influence of dialysis-related amyloidosis on QOL
Date of disclosure of the study information 2013/12/25
Last modified on 2015/08/03 02:18:40

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Basic information

Public title

Cross-sectional epidemiological study on patients receiving maintenance hemodialysis for more than 10 years: Research on the influence of dialysis-related amyloidosis on QOL

Acronym

Research on the influence of dialysis-related amyloidosis on QOL

Scientific Title

Cross-sectional epidemiological study on patients receiving maintenance hemodialysis for more than 10 years: Research on the influence of dialysis-related amyloidosis on QOL

Scientific Title:Acronym

Research on the influence of dialysis-related amyloidosis on QOL

Region

Japan


Condition

Condition

Chronic kindney disease requiring maintenance hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the symptoms of dialysis-related amyloidosis in patients receiving maintenance hemodialysis for more than 10 years, and evaluate the impact on QOL.

Basic objectives2

Others

Basic objectives -Others

survey

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

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) Receiving hemodialysis for more than 10 years
(2) Age at informed consent is not less than 20 years
(3) Obtained written informed consent from the patient

Key exclusion criteria

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Hirakata

Organization

Japanese Red Cross Fukuoka Hospital

Division name

Division of Nephrology and Dialysis Center

Zip code


Address

3-1-1 Ookusu, Minami-ku, Fukuoka 815-8555, Japan

TEL

-

Email

otsuka@npo-cic.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

-

Homepage URL

http://www.qdra.net/

Email

otsuka@npo-cic.jp


Sponsor or person

Institute

Kyushu Dialysis-Related Amyloidosis Study Group

Institute

Department

Personal name



Funding Source

Organization

Kyushu Dialysis-Related Amyloidosis Study Group

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

九州、沖縄の透析施設(レジストリ研究)


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 25 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

2013 Year 04 Month 03 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 01 Day

Last follow-up date

2014 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information


Management information

Registered date

2013 Year 12 Month 25 Day

Last modified on

2015 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013690


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name