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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028064
Receipt No. R000032130
Scientific Title The association of erythropoiesis-stimulating agent resistance index (ERI), serum fetuin-A with butyrylcholinesterase in hemodialysis patients
Date of disclosure of the study information 2017/07/06
Last modified on 2018/07/05

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Basic information
Public title The association of erythropoiesis-stimulating agent resistance index (ERI), serum fetuin-A with butyrylcholinesterase in hemodialysis patients
Acronym The association of erythropoiesis-stimulating agent resistance index (ERI), serum fetuin-A with butyrylcholinesterase in hemodialysis patients
Scientific Title The association of erythropoiesis-stimulating agent resistance index (ERI), serum fetuin-A with butyrylcholinesterase in hemodialysis patients
Scientific Title:Acronym The association of erythropoiesis-stimulating agent resistance index (ERI), serum fetuin-A with butyrylcholinesterase in hemodialysis patients
Region
Japan

Condition
Condition Chronic kidney disease with hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To invertigate correlationship between erythropoiesis-stimulating agent resistance index (ERI), the serum fetuin-A level and the serum butyrylcholinesterase level in hemodialysis patients
Basic objectives2 Others
Basic objectives -Others Invertigate of correlationship
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To investigate the degree of correlationship between ERI,serum fetuin-A level and serum butyrylcholinesterase level
Key secondary outcomes To determine multiple liner regression equation of fetuin-A and ERI

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
100 years-old >
Gender Male and Female
Key inclusion criteria Hemodialysis patients in Oyokyo kidney research institute Aomori hospital
Key exclusion criteria patients with active infection, autoimmune disease, active hepatitis, liver cirrhosis, and obvious cancerous cachexia.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University, Graduate School of Med
Division name Urology
Zip code
Address 53 Hontyou, Hirosaki
TEL 0172-39-5091
Email shingorilla2@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Teppei Okamoto
Organization Oyokyo Kidney Research Institute Aomori Hospital
Division name Urology
Zip code
Address 101-1 Okabe, Ishie, Aomori
TEL 017-781-9331
Homepage URL
Email tepperococcus@yahoo.co.jp

Sponsor
Institute Oyokyo Kidney Research Institute Aomori Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 07 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1007/s10157-018-1569-z
Number of participants that the trial has enrolled
Results
We demonstrated the independent relationship between BChE and serum fetuin-A in patients on HD.
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 Main results already published
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 15 Day
Last follow-up date
2018 Year 04 Month 06 Day
Date of closure to data entry
2018 Year 04 Month 10 Day
Date trial data considered complete
2018 Year 04 Month 10 Day
Date analysis concluded
2018 Year 04 Month 20 Day

Other
Other related information Study type:cross sectional study
Object: hemodialysis Patients in Oyokyo kidney research institute Aomori Hospital

Management information
Registered date
2017 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032130

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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