UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015419 |
|---|---|
| Receipt number | R000017921 |
| Scientific Title | The efficacy of AST-120 on chronic kidney disease with stable angina: randomized controlled open-labeled trial |
| Date of disclosure of the study information | 2014/12/20 |
| Last modified on | 2018/04/15 10:58:17 |
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Basic information
Public title
The efficacy of AST-120 on chronic kidney disease with stable angina: randomized controlled open-labeled trial
Acronym
The efficacy of AST-120 on chronic kidney disease with stable angina
Scientific Title
The efficacy of AST-120 on chronic kidney disease with stable angina: randomized controlled open-labeled trial
Scientific Title:Acronym
The efficacy of AST-120 on chronic kidney disease with stable angina
Region
| Japan |
Condition
Condition
Ischemic heart disease
Chronic kidney disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of AST-120 to carotid intima thickness and the vascular endothelial function in patients with coronary artery disease comorbid with chronic kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change of carotid intima-media thickness
The amount of change of vascular endothelial function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
AST-120
Interventions/Control_2
control
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
stable angina
eGFR 15-45ml/min/1.732
Key exclusion criteria
patients with pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoaki Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL
052-744-2150
murohara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Suzuki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of CKD Initiatives Internal Medicine
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL
052-744-2202
Homepage URL
susumusuzuki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, Nagoya University Graduate School of Medicine
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
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
名古屋大学病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 20 | 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
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 12 | Day |
Last modified on
| 2018 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017921
