Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY

UMIN ID: UMIN000001324

Registered date:22/08/2008

Basic Information

• Health condition(s) or Problem(s) studied: Type 2 diabetic nephropathy with Hypercholesterolemia
• Date of first enrollment: 2008/08/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Pitavastatin treatment group
Pravastatin treatment group

Outcome(s)

• Primary Outcome: Changes in urinary albumin/creatinine ratio,Changes in eGFR
• Secondary Outcome: urinary albumin/creatinine ratio, serum creatinine , Urea nitrogen, serum cystein C, LDL-C,TC,TG,HDL-C,non HDL-C, 8-isoprostane, urinary L-FABP, urinary typeIV collagen

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1."Contraindications""Relative Contraindications""Absolute Contraindications for Coadministration" and "Relative Contraindications for Coadministration" for pitavastatin or pravastatin 2.Patients with hypothyroidism or inherited muscle disorder (muscular dystrophy etc.) and patients with a previous history of drug-induced myopathy 3.Non- diabetic nephropathy 4. Renal dysfunction (s-Cr over 1.5 mg/dl) 5.Urinary tract infection 6.Uncontrolled diabetes, defined as HbA1c>10.0% 7.Malignancy 8. Stroke 9. Heart failure (NYHA Class >= III) or myocardial infarction 10.Angina with symptom 11.Participating in clinical trials or clinical research 12.Judged as unsuitable for participating in this study by the attending physician

Related Information

• Primary Sponsor: Kyushu University Graduate School of Medical Science Department of Medicine and Bioregulatory Science
• Source(s) of Monetary Support: none