UMIN-CTR Clinical Trial

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 Shingo Middle name Last name Hatakeyama
Organization	Hirosaki University, Graduate School of Med
Division name	Urology
Zip code	036-8562
Address	Hirosaki
TEL	0172550980
Email	shingorilla2@gmail.com

Public contact
Name of contact person	1st name Teppei Middle name Last name Okamoto
Organization	Hirosaki University School of Medicine
Division name	Urology
Zip code	036-8562
Address	Hirosaki
TEL	0172395091
Homepage URL
Email	uroyone@hirosaki-u.ac.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	IRB
Address	Hirosaki
Tel	0172-39-5194
Email	rinri@hirosaki-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	2017 Year 07 Month 06 Day

Related information
URL releasing protocol	https://doi.org/10.1007/s10157-018-1569-z
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	215
Results	We demonstrated the independent relationship between BChE and serum fetuin-A in patients on HD.
Results date posted	2022 Year 12 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Erythropoiesis-stimulating agent (ESA) responsiveness is related to the nutritional status of patients on hemodialysis (HD). Serum butyrylcholinesterase (BChE), an alpha-glycoprotein, may decrease in case of malnutrition. We investigated whether BChE was independently related to ESA resistance in patients on HD.
Participant flow	The laboratory data and ESA resistance index (ERI), defined as ESA dosage per week divided by dry weight and hemoglobin, were investigated in 215 patients on HD between July and September 2017.
Adverse events	None
Outcome measures	Factors independently associated with higher ERI were determined using multivariate logistic regression analysis.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 01 Day
Date of IRB	2016 Year 01 Month 26 Day
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	2022 Year 12 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032130