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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009417
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tosei General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011066

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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