The Use of Cilostazol in Patients With Diabetic Nephropathy

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with type 2 diabetes have a long duration of disease for the development of complications. Among all complications, microangiopathic complications are major causes of mortality and morbidity in diabetic patients. In Asia, patients with type 2 diabetes are particularly susceptible to the development of kidney disease. Patients with diabetic kidney disease have more adverse metabolic profiles and increased risk of having other complications such as blindness, stroke, heart attack and nerve damage than those without. Despite receiving the best of care, the combined event rate of death, cardiovascular disease and end stage kidney disease in diabetic patients with renal impairment remained as high as 10% per year.

Cilostazol reduces platelet aggregation and prevents formation of blood clots. Furthermore, cilostazol treatment has been shown to reduce serum triglyceride concentrations and increase HDL-cholesterol levels. In this randomized placebo-controlled, double-blinded study, the investigators hypothesize that Cilostazol may reduce the rate of decline in renal function in Chinese patients with type 2 diabetes and mild to moderate renal impairment. Sixty patients will be randomised to receive either Cilostazol 100 mg twice daily or placebo for 12 months. The effect of Cilostazol on the progression of diabetic nephropathy, as defined by rates of decline in glomerular filtration rate, serum creatinine and urinary albumin excretion rate will be measured. The results will provide additional insight on the management of diabetic kidney disease which is prevalent among Chinese diabetic patients in Hong Kong.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Cilostazol

Criteria

Inclusion Criteria:

1. Male or female patients aged between 20 and 70 years

2. Patients with Type 2 diabetic mellitus

3. A fasting urinary albumin/creatinine ratio greater than or equal to 30 mg/mmol or 24 hour urinary albumin excretion greater than or equal to 300 mg/day in two urine collections during the baseline period

4. Two consecutive serum creatinine levels during baseline period which meet the following requirements:

• Women: between 80 umol/l and 250 umol/l (inclusive)

• Men: between 105 umol/l and 250 umol/l (inclusive)

5. Written informed consent

Exclusion Criteria:

• Pregnancy

• Known allergy to cilostazol or aspirin

• Congestive heart failure (NYHA class III to IV)

• Severe liver impairment (greater than or equal to 3 times ULN of ALT)

• Serum potassium levels greater than or equal to 5.5 mmol/l on 2 consecutive specimens