Effect of Pitavastatin on Amelioration for Renal Function in Patients with Chronic Kidney Disease

UMIN ID: UMIN000001600

Registered date:20/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypercholesterolemia patients evaluated inulin clearance with chronic kidney disease (stage 3)
• Date of first enrollment: 2009/02/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Pitavastatin 1 mg or 2 mg daily for a period of 6 months

Outcome(s)

• Primary Outcome: Amount of change in inulin clearance
• Secondary Outcome: 1)Comparison of a percent and amount change in inulin clearance and eGFR among baseline matched CKD stage3 patients who is under medical care in Nagoya University Hospital without statins prescription 2)A percent change in inulin clearance 3)A percent and amount of change in following factors 1.Serum lipid profile (TC, LDL-C, HDL-C, TG) 2.The laboratory parameters (AST, ALT, gamma-GTP, CK, and the other) 3.The laboratory parameters(RBC, WBC, Ht, and the other) 4.The special laboratory parameters (hs-CRP, 8-OHdG, alpha1 globulin, beta2 globulin, creatine) 5.Urinary protein (Urinary albumin)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: (1)Patients whose creatine levels change more than 25% in past 1 year. (2)Patients who are planed to change drugs for CKD. (3)Known hypersensitivity or history of clinically significant adverse reactions to Livalo. (4)Patients with serious hepatopathy or biliary obstruction. (5)Patients who are being treated with cyclosporine. (6)Pregnant, possibly pregnant, or lactating. (7)Patients who do not accept informed consent. (8)Patients who are judged unsuitable for this study by the doctor in charge of that patients.

Related Information

• Primary Sponsor: Nagoya University, Graduate School of Medicine
• Source(s) of Monetary Support: None