UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049856 |
|---|---|
| Receipt number | R000056779 |
| Scientific Title | A study on the difference in the removal rate of insulin and glucagon for each dialyzer in hemodiafiltration. |
| Date of disclosure of the study information | 2022/12/26 |
| Last modified on | 2023/06/06 22:44:05 |
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Basic information
Public title
A study on the difference in the removal rate of insulin and glucagon for each dialyzer in hemodiafiltration.
Acronym
A study on the difference in the removal rate of insulin and glucagon for each dialyzer in hemodiafiltration.
Scientific Title
A study on the difference in the removal rate of insulin and glucagon for each dialyzer in hemodiafiltration.
Scientific Title:Acronym
A study on the difference in the removal rate of insulin and glucagon for each dialyzer in hemodiafiltration.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure whether there is no concentration change for each dialyzer in dialysis patients who are suffering from type 2 diabetes and are undergoing hemodiafiltration, and to what extent the adsorption of the dialyzer is affected.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Removal rate calculated from insulin and glucagon levels on the blood-receiving side and blood-receiving side immediately before the end of hemofiltration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Type 2 diabetes
Interventions/Control_2
Hemodiafiltration
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
Persons undergoing hemodiafiltration
Persons with type 2 diabetes
Subjects whose blood insulin concentration was 30 micro-IU/ml or higher after the introduction of dialysis therapy
Over 20 years old
Key exclusion criteria
Those who have requested refusal to participate in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Abe |
Organization
Nihon University School of Medicine
Division name
Department of Nephrology, Hypertension,an Endocrinology
Zip code
1738610
Address
30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
TEL
+81-3-3972-8111
abe.masanori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Maruyama |
Organization
Nihon University School of Medicine
Division name
Department of Nephrology, Hypertension,an Endocrinology
Zip code
1738610
Address
30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
TEL
+81-3-3972-8111
Homepage URL
maruyama.takashi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
Tel
+81-3-3972-8111
komoda.nozomi@nihon-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
| 2022 | Year | 12 | Month | 26 | 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
20
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
| 2022 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056779
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
