A multicenter randomized study evaluating the efficacy and safety of HMG-CoA reductase inhibitors (statins) in dyslipidemic patients with nephrosclerosis.

A multicenter randomized study evaluating the efficacy and safety of HMG-CoA reductase inhibitors (statins) in dyslipidemic patients with nephrosclerosis. - Prospective evaluation of eGFR in CKD with nephrosclerosis by lipid intervention study (LAKE study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007130

Enrollment

100

Registered

2012-01-24

Start date

2011-06-01

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

Nephrosclerosis

Interventions

Pitavastatin group Control group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Nephrosclerotic patients whose serum LDL-C levels are lower than the levels of management goals recommended by guidline 2. eGFR<60mL/min/1.73m2 3. Proteinuria<0.5g/day(or <0.5g/gCr) 4. HbA1c<6.5%(NGSP) 5. Patients 20 years or older at the time of provision of consent 6. Patients who are treated with anti-hypertensive drugs

Exclusion criteria

Exclusion criteria: 1. Patients who are treated with statins 2. Patients who are planned to start or change medication for renal disease 3. Severe hypertensive patients (SBP>=150mmHg or DBP >=90mmHg) 4. Severe hepatic dysfunction 5. Abnormal values of serum creatinine caused by any disease except renal disease 6. BMI>25(kg/m2) 7. Patients with thyroid dysfunction 8. History of acute myocardial infarction or stroke during three months prior to the registration 9. Pregnant, breast feeding, or could be pregnant 10. Patients who do not accept informed consent 11. Patients judged as being inappropriate for this study by investigators

Design outcomes

Primary

Measure	Time frame
An absolute change of estimated glomerular filtration rate	—

Secondary

Measure	Time frame
1. An absolute change of renal function -urinary albumin or protein, serum creatinine, urinary beta 2 microglobulin(BMG), urinary N-acetyl-beta-D-glucosaminidase(NAG) 2. An absolute change of serum lipids -TC, LDL-C, TG, HDL-C, non HDL-C, apolipoprotein(Apo A-I, Apo A-II, ApoB)	—

Countries

Japan

Contacts

Public ContactTsuguru Hatta

Omihachiman Community Medical Center Division of Nephrology

tsuguhatta@hotmail.com0748-33-3151

Outcome results

None listed

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