Non-dialysis chronic kidney disease
Conditions
Interventions
Oral administration of AST-120 and magnesium oxide
Oral administration of only AST-120
Oral administration of only magnesium oxide
Oral administration of neither AST-120 nor magnesium
Sponsors
Osaka University Graduate School of Medicine, Geriatric Medicine and Nephrology
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in coronary artery calcification score (CACS) and a proportion of patients with more than 15 percent annualized increases in CACS | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYusuke Sakaguchi
Osaka University Graduate School of Medicine Nephrology
Outcome results
None listed