UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009417 |
|---|---|
| Receipt number | R000011066 |
| Scientific Title | A prospective randomized trial on the effects of AST-120 against progression of coronary artery calcification in Chronic Kidney Disease (CKD) patients |
| Date of disclosure of the study information | 2012/11/28 |
| Last modified on | 2012/11/28 14:46:12 |
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Basic information
Public title
A prospective randomized trial on the effects of AST-120 against progression of coronary artery calcification in Chronic Kidney Disease (CKD) patients
Acronym
CACTUS (slow Cardiac Artery Calcification in Tosei general hospital by Using Spherical carbon adsorbent)
Scientific Title
A prospective randomized trial on the effects of AST-120 against progression of coronary artery calcification in Chronic Kidney Disease (CKD) patients
Scientific Title:Acronym
CACTUS (slow Cardiac Artery Calcification in Tosei general hospital by Using Spherical carbon adsorbent)
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of AST-120 to slow progression of coronary artery calcification in CKD patients, compared with non-administration group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
coronary artery calcification score at 36 months
Key secondary outcomes
1. eGFR, BUN and BNP at 36 months
2. coronary artery calcification score at 24 and 36 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with AST-120 (6g/day) for 3 years
Interventions/Control_2
Conventional treatment without AST-120 for 3 years
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
1) Patients who have moderate chronic kidney disease
*eGFR: 30-59 ml/min/1.73m2
2) Patients who are aged 20 years or older at the time of obtaining informed consent
3) Patients who have personally and voluntarily provided written informed consent, after having received and thoroughly understood an adequate explanation about participation in the study.
Key exclusion criteria
1) Patients receiving AST-120
2) Patients who have gastrointestinal obstruction
3) Women of confirmed or potential pregnancy
4) Patients who participated in other clinical trials within 3 months of administrating the experimental drugs
5) Patients who are judged unsuitable for this study by the doctor in charge of the patients
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | AJIOKA Masayoshi |
Organization
Tosei General Hospital
Division name
Department of Cardiology
Zip code
Address
160, NISHIOIWAKE-CHO, SETO, AICHI 489-8642
TEL
0561-82-5101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | AJIOKA Masayoshi |
Organization
Tosei General Hospital
Division name
Department of Cardiology
Zip code
Address
160, NISHIOIWAKE-CHO, SETO, AICHI 489-8642
TEL
0561-82-5101
Homepage URL
Sponsor or person
Institute
Tosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2012 | Year | 11 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 28 | Day |
Last modified on
| 2012 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011066
| 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 |
