UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033365
Receipt number R000038035
Scientific Title Kyusyu Prospective Cohort Study in Hemodialysis Patients
Date of disclosure of the study information 2018/09/01
Last modified on 2020/01/10 09:32:48

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Basic information

Public title

Kyusyu Prospective Cohort Study in Hemodialysis Patients

Acronym

Q-Cohort Study

Scientific Title

Kyusyu Prospective Cohort Study in Hemodialysis Patients

Scientific Title:Acronym

Q-Cohort Study

Region

Japan


Condition

Condition

Chronic hemodialysis patients

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate complications and prognosis of patients on Chronic Hemodialysis

Basic objectives2

Others

Basic objectives -Others

To investigate the best hemodialysis prescription to patients on chronic hemodialysis

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Death (cardiovascular cause, infectious disease, malignancy)

Key secondary outcomes

Coronary heart disease, stroke, peripheral artery disease, bone fracture


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

Patients undergoing chronic hemodialysis

Key exclusion criteria

Physician decides the patient inappropriate to participate

Target sample size

3600


Research contact person

Name of lead principal investigator

1st name Takanari
Middle name
Last name Kitazono

Organization

Kyushu University

Division name

Department of Medicine and Clinical Science

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

092-642-5843

Email

kitazono@intmed2.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Toshiaki
Middle name
Last name Nakano

Organization

Kyushu University

Division name

Department of Medicine and Clinical Science

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

092-642-5843

Homepage URL


Email

toshink@med.kyushu-u.ac.jp


Sponsor or person

Institute

ARO Next Generation Medical Center

Institute

Department

Personal name



Funding Source

Organization

Fukuoka Renal Clinic

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

Center for clinical and translational research

Address

3-1-1 Maidashi, Higashi-ku

Tel

0926425774

Email

bynintei@jimu.kyushu-u.ac.jp


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

2018 Year 09 Month 01 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 09 Month 01 Day

Date of IRB

2018 Year 10 Month 24 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2028 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study


Management information

Registered date

2018 Year 07 Month 11 Day

Last modified on

2020 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038035


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name