UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028064 |
|---|---|
| Receipt number | 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 | 2022/12/05 22:33:59 |
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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 | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University, Graduate School of Med
Division name
Urology
Zip code
036-8562
Address
Hirosaki
TEL
0172550980
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
uroyone@hirosaki-u.ac.jp
Sponsor or person
Institute
Oyokyo Kidney Research Institute Aomori Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032130
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