UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009738 |
|---|---|
| Receipt number | 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 | 2022/03/22 20:47:02 |
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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
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
yusuke7771@gmail.com
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Geriatric Medicine and Nephrology
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 08 | Day |
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
| 2022 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010546
