UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050805 |
|---|---|
| Receipt number | R000057853 |
| Scientific Title | Influence of protein ingestion on dynamics in amino acids during hemodialysis |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2024/03/11 08:16:10 |
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Basic information
Public title
Influence of protein ingestion on dynamics in amino acids during hemodialysis
Acronym
Influence of protein ingestion on dynamics in amino acids during hemodialysis
Scientific Title
Influence of protein ingestion on dynamics in amino acids during hemodialysis
Scientific Title:Acronym
Influence of protein ingestion on dynamics in amino acids during hemodialysis
Region
| Japan |
Condition
Condition
Hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of protein ingestion on dynamics in amino acids during hemodialysis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in plasma amino acids concentration by ingestion of protein during hemodialysis
Key secondary outcomes
Change in spent dialysate amino acids blood concentration by ingestion of protein during hemodialysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of protein during hemodialysis
Interventions/Control_2
Ingestion of another protein during hemodialysis
Interventions/Control_3
Usual care
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients on hemodialysis therapy for at least 3-month
2. Patients aged 60 and older
3. Patients who signed an informed consent
Key exclusion criteria
1. Patients with excessive weight gain between dialysis sessions
2. Patients who have a risk of severe dialysis-related complication
3. Patients who have hemodynamic instabilities
4. Patients with cognitive impairment
5. Patients who are identified as unsuitable for participation in the trial by an attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Matsuzawa |
Organization
Hyogo Medical University
Division name
Graduate School of Health Science
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo Ward, Kobe, Hyogo
TEL
078-304-3181
ri-matsuzawa@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Matsuzawa |
Organization
Hyogo Medical University
Division name
Graduate School of Health Science
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo Ward, Kobe, Hyogo
TEL
078-304-3181
Homepage URL
ri-matsuzawa@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Ryota Matsuzawa
Funding Source
Organization
Hyogo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nissui Corporation
Name of secondary funder(s)
Nissui Corporation
IRB Contact (For public release)
Organization
The Ethics Review Board of Hyogo Medical University
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798-45-6066
rinri@hyo-med.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
| 2023 | Year | 06 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057853
| 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 |
