Evaluate the Efficacy of Fenofibrate on Microalbuminuria

Launched by BEIJING CHAO YANG HOSPITAL · Dec 9, 2014

Keywords

ClinConnect Summary

Diabetes has become a major public health problem in China, and a large-scale epidemiological survey revealed a prevalence of 9.7% approximately 5 years ago \[1\]. Diabetic nephropathy (DN) is the most common microvascular complication and is a major cause of end-stage renal disease that requires dialysis and/or renal transplantation \[2\]. Thus, strategies aimed at the treatment of DN are as important as those that target diabetes itself. Diabetic nephropathy is associated with mesangial cell expansion, thickening of glomerular and tubular basement membrane, glomerulosclerosis and tubular ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Females or males, and aged 20 to 65 years.
• • Type 2 diabetes with microalbuminuria (Urinary albumin /creatinine ratio, ACR, between 30 and 300 mg/g, a first morning spot urine sample will be used to approximate the 24-hour urine albumin excretion) in two consecutive laboratory tests before the study period.
• • At least 2 months statin monotherapy with low to moderate dose (atorvastatin ≤20mg q.d. or rosuvastatin≤10mg q.d. or simvastatin≤40mg q.d. or pravastatin≤40mg q.d.or pitavastatin≤2mg q.d or fluvastatin≤80mg q.d.or lovastatin≤40mg q.d) prior to enrollemnt and plan to continue the same type and dose of statin.
• • TG≥1.7 mmol/L (150mg/dl) and TG\<5.65 mmol/L (500mg/dl).
• • HbA1C\<8% and blood pressure\<140/90mmHg.
• Exclusion Criteria:
• • Any contraindication of fenofibrate and statins in Chinese label.
• • Hepatic insufficiency (ALT or AST\> 1.5\*ULN)
• • Renal insufficiency \[Creatinine clearance rate (Ccr)\]\<60ml/min estimated from MDRD equation)
• • CK \> 1.5\*ULN
• • Hypothyroidism
• • Use of non-statin lipid-regulating drugs such as niacin and fish oil in previous 1 month
• • Combination use of other fibrates or drug with similar structure, especially ketoprofen
• • Combination use of oral anticoagulants
• • Pregnant or lactating woman
• • Other conditions at investigator's discretion