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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009738
Receipt No. R000010546
Scientific Title The therapeutic effects of AST-120 and/or magnesium on coronary artery calcification in chronic kidney disease: A Randomized Controlled Trial
Date of disclosure of the study information 2013/01/09
Last modified on 2018/04/20

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Basic information
Public title The therapeutic effects of AST-120 and/or magnesium on coronary artery calcification in chronic kidney disease: A Randomized Controlled Trial
Acronym The therapeutic effects of AST-120 and/or magnesium on coronary artery calcification in chronic kidney disease: A Randomized
Scientific Title The therapeutic effects of AST-120 and/or magnesium on coronary artery calcification in chronic kidney disease: A Randomized Controlled Trial
Scientific Title:Acronym The therapeutic effects of AST-120 and/or magnesium on coronary artery calcification in chronic kidney disease: A Randomized
Region
Japan

Condition
Condition Non-dialysis chronic kidney disease
Classification by specialty
Cardiology Nephrology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether treatment with AST-120 and/or magnesium prevent cardiovascular disease and the progression of vascular calcification and to explore new biomarkers associated with the severity and progression of cardiovascular disease and vascular calcification in patients with non-dialysis chronic kidney disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in coronary artery calcification score (CACS) and a proportion of patients with more than 15 percent annualized increases in CACS
Key secondary outcomes An incident cardiovascular event requiring hospitalization, the change in several biomarkers associated with vascular calcification, and gastrointestinal adverse events such as constipation and abdominal distension, renal outcome (eGFR slope), the change in calcification score in the following lesion; pericardium, myocardium, aorta, mitral valve, aortic valve

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of AST-120 and magnesium oxide
Interventions/Control_2 Oral administration of only AST-120
Interventions/Control_3 Oral administration of only magnesium oxide
Interventions/Control_4 Oral administration of neither AST-120 nor magnesium
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Outpatients of Osaka University hospital
2) Patient with chronic kidney disease stages 3 and 4: estimated glomerular filtration rate 15-59mL/min/1.73m2
3) Patients with either of the following conditions;
a) diabetes
b) prior cardiovascular disease
c) hyper-LDL cholesterolemia (LDL cholesterol levels >= 140 mg/dL or those prescribed statins)
d) current smoking
4) Written consent to participation in this study has been obtained from the patient
Key exclusion criteria 1) Patients already treated with AST-120 or magnesium at enrollment
2) Patients with prior allergies to AST-120 or magnesium
3) Patients with coronary stent
4) Patients expected to initiate dialysis within 1 year
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Isaka
Organization Osaka University Graduate School of Medicine
Division name Geriatric Medicine and Nephrology
Zip code
Address 2-2 B6, Yamada-oka Suita, Osaka
TEL +81-6-6879-3857
Email isaka@kid.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Sakaguchi
Organization Osaka University Graduate School of Medicine
Division name Nephrology
Zip code
Address 2-2 B6, Yamada-oka Suita, Osaka
TEL +81-6-6879-3857
Homepage URL
Email yusuke7771@gmail.com

Sponsor
Institute Osaka University Graduate School of Medicine, Geriatric Medicine and Nephrology
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine, Geriatric Medicine and Nephrology
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
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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 09 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 Open public recruiting
Date of protocol fixation
2012 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information [Sample size analysis and Interim Analysis]
We estimated that a sample size of 222 patients (111 in each group) would provide a power of 90% at an overall two-sided alpha error level of 0.05 to detect a 30% relative reduction in the percent change in CAC scores in the magnesium oxide group compared to the control group, given that an annual percent change in CAC score among pre-dialysis diabetic CKD patients was 14% according to a previous study. Assuming a dropout rate of approximately 10%, we planned to enroll a total of 250 patients.
An interim analysis for efficacy was to be performed after a half of the planned number of patients (i.e., 125 patients) reached the end of the study, with use of the Lan-DeMets alpha-spending-function approach (Pocock type).
According to a result of the interim analysis, an independent data monitoring committee determines whether the study should be continued or prematurely terminated.

Management information
Registered date
2013 Year 01 Month 09 Day
Last modified on
2018 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010546

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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