Assessment of clinical usefulness in CKD patients with atorvastatin trial (ASUCA Trial)

UMIN ID: UMIN000001778

Registered date:17/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hyperlipidemia with Chronic Kidney Disease (CKD)
• Date of first enrollment: 2009/04/01
• Target sample size: 330
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients are given atorvastatin 10 mg/day under dietary therapy based on the "Clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease" and "Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases". The dosage of atorvastatin can be increased up to 20mg/day when atorvastatin 10 mg/day fails to achieve the LDL-cholesterol target (less than 100mg/dL). When the target is not achieved with atorvastatin 20mg/day, antihyperlipidemic drugs except the other statins and fibrates can be added.
Patients are treated with dietary therapy alone based on the "Clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease" and "Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases". Antihyperlipidemic durugs except statins can be administered when dietary therapy alone fails to achieve the LDL-cholesterol target (less than 100mg/dL) after three months. When patients have already been treated with antihyperlipidemic drugs except statins at enrollment, the drugs can be continued.

Outcome(s)

• Primary Outcome: Change in eGFR
• Secondary Outcome: 1) change in LDL-cholesterol, 2) change in triglyceride, 3) change in urinary albumin (mg/g*Cr), 4) cardiovascular event, 6) all-cause death, 8) safety parameters

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) hepatic disease with decreased liver function, 2) familial hypercholesterolaemia, 3) eGFR less than 30 ml/min/1.73m2, 4) uncontrolled hypertension (systolic blood pressure of 180 mmHg or greater or diastolic blood pressure of 110 mmHg or greater), 5) poor controlled diabetics (HbA1c of 8.5% or greater), 6) nephrotic syndrome, 7) pregnancy or breast feeding, 8) known intolerance/adverse effects to atorvastatin, 9) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Related Information

• Primary Sponsor: Kyoto University Graduate School of Medicine
• Source(s) of Monetary Support: Department account fund