UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040111 |
|---|---|
| Receipt number | R000045736 |
| Scientific Title | pH-Dependent Protein Binding Property of Uremic Toxins in vitro |
| Date of disclosure of the study information | 2020/04/08 |
| Last modified on | 2022/10/10 17:24:51 |
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Basic information
Public title
pH-Dependent Protein Binding Property of Uremic Toxins in vitro
Acronym
pH-Dependent Protein Binding Property of Uremic Toxins in vitro
Scientific Title
pH-Dependent Protein Binding Property of Uremic Toxins in vitro
Scientific Title:Acronym
pH-Dependent Protein Binding Property of Uremic Toxins in vitro
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of pH on the protein-binding property of uremic toxins
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentration of serum free uremic toxins
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
Chronic kidney disease patients undergoing hemodialysis treatment
Key exclusion criteria
Non dialysis patients
Target sample size
20
Research contact person
Name of lead principal investigator
| 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 950-8510, Japan
TEL
0252272200
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 ,Japan
TEL
0252272200
Homepage URL
yamamots@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital, Division of Blood Purification Therapy
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Niigata University Medical and Dental Hospital
Address
1-757 Asahimachi-dori, Niigata, 951-8510 ,Japan
Tel
0252272200
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 | 08 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6651/13/2/116
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6651/13/2/116
Number of participants that the trial has enrolled
19
Results
The addition of human serum to each toxin resulted in increased free forms at acidic and alkaline pH. The pH values of serums from patients undergoing hemodialysis adjusted to 3.4 and 11.3, resulting in increased concentrations of the free forms of PBUTs. In conclusion, acidic and alkaline pH conditions changed the albumin conformation and weakened the protein binding property of PBUTs in vitro.
Results date posted
| 2022 | Year | 10 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Maintenance hemodialysis patients.
Participant flow
Patients joined the study with written informed consent. Patients were drawn blood before the hemodialysis session.
Adverse events
None
Outcome measures
Serum levels of total and free uremic toxins with pH 3-11.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A cross-sectional study
Management information
Registered date
| 2020 | Year | 04 | Month | 08 | Day |
Last modified on
| 2022 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045736
| 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 |
