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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001778
Enrollment
330
Registered
2009-03-17
Start date
2009-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia with Chronic Kidney Disease (CKD)

Interventions

Patients are given atorvastatin 10 mg/day under dietary therapy based on the &quot
Clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease&quot
and &quot
Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases&quot
. 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 atorvast
. 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 alread

Sponsors

Kyoto University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) written informed consent, 2) age: from 40 to 74 years old, 3) either positive urine protein test or eGFR less than 60 ml/min/1.73m2 three months before enrollment, 4) eGFR less than 60 ml/min/1.73m2 at enrollment, 5) LDL-cholesterol of 140mg/dL or greater (LDL-cholesterol of 100mg/dL or greater if patients have already received an antihyperlipidemic drugs), 6) patient who are not treated with statins

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Change in eGFR

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactDepartment of EBM Research

Kyoto University Hospital iACT

asucatrial@mail2.adm.kyoto-u.ac.jp0120-105894

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026