UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009618 |
|---|---|
| Receipt number | R000011284 |
| Scientific Title | AST-120 for decreasing circulating protein-bound uremic toxins in hemodialysis patients. |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2013/06/24 12:22:49 |
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Basic information
Public title
AST-120 for decreasing circulating protein-bound uremic toxins in hemodialysis patients.
Acronym
AST-120 for decreasing circulating protein-bound uremic toxins in hemodialysis patients.
Scientific Title
AST-120 for decreasing circulating protein-bound uremic toxins in hemodialysis patients.
Scientific Title:Acronym
AST-120 for decreasing circulating protein-bound uremic toxins in hemodialysis patients.
Region
| Japan |
Condition
Condition
Chronic kidney disease undergoing hemodialysis treatment.
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether AST-120 reduces circulating protein-bound uremic toxins in hemodialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reducing the level of circulating protein-bound uremic toxins.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Use of AST-120
Interventions/Control_2
Not use of AST-120
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Maintenance hemodialysis patients
Key exclusion criteria
Patients who need hospitalization with complications
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suguru Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Clinical Nephroscience
Zip code
Address
1-757 Ashahimachi-dori, Chuou-ku, Niigata, 951-8510, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Clinical Nephroscience
Zip code
Address
TEL
Homepage URL
yamamots@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences
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
Address
Tel
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
| 2013 | Year | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 24 | Day |
Last modified on
| 2013 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011284
