UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039972 |
|---|---|
| Receipt number | R000045574 |
| Scientific Title | Protein-bound uremic toxins and nutritional status in hemodialysis patients |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2024/04/01 18:33:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Protein-bound uremic toxins and nutritional status in hemodialysis patients
Acronym
Protein-bound uremic toxins and nutritional status in hemodialysis patients
Scientific Title
Protein-bound uremic toxins and nutritional status in hemodialysis patients
Scientific Title:Acronym
Protein-bound uremic toxins and nutritional status in hemodialysis patients
Region
| Japan |
Condition
Condition
Maintenance hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the associations between serum level of protein-bound uremic toxins and several nutritional markers in maintenance hemodilaysis patients
Basic objectives2
Others
Basic objectives -Others
Dietary intake of protein will improve nutritional status in hemodialysis patients, while it may increase the production of uremic toxins.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum level of protein-bound uremic toxins including indoxy sulfate, p-cresyl sulfate, indole acetic acid, and phenyl sulfate), and nutritional indicators including serum level of albumin, creatinine, GNRI, and nPCR.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Patients undergoing maintenance hemodialysis treatment
Key exclusion criteria
Patients who are not undergoing maintenance hemodialysis treatment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | Yamamoto |
| Last name | Yamamoto |
Organization
Niigata university medical and dental hospital
Division name
Division of Blood Purification Therapy
Zip code
951-8520
Address
1-757 Asahimachi-dori, Niigata 951-8510
TEL
0252272770
yamamots@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Blood Purification Therapy
Zip code
950-8510
Address
1-757 Asahimachi-dori, Niigata 951-8510
TEL
0252272770
Homepage URL
yamamots@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
1-757 Asahimachi-dori, Niigata 951-8510
Tel
0252272770
yamamots@med.niigata-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
| 2020 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
200
Results
We have collected samples, and are examining the analysis of the relation between serum uremic toxin level and nutritional parameters.
Results date posted
| 2021 | Year | 09 | Month | 29 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
We have delayed the analysis
Date of the first journal publication of results
Baseline Characteristics
Maintenance hemodialysis patients
Participant flow
All patients provided written informed consent, and were collected blood samples.
Adverse events
None
Outcome measures
Serum uremic toxin level and nutritional parameters
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional study, and the data has been already available.
Management information
Registered date
| 2020 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045574
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
