NCT00108485

Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy

Randomized, Double-blind, Placebo-controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to test the effectiveness and tolerability of Niaspan® to improve the levels of blood fats ("good" and "bad" cholesterol and triglyceride levels) in people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan® slows down further development of kidney damage.

Detailed description

Diabetic nephropathy is the leading cause of end stage kidney disease in the United States. Patients with chronic kidney disease have a markedly increased risk of death from cardiovascular disease, and traditional risk factors such as hyperlipidemia have been shown to be of critical importance. Almost 90% of patients with diabetes and chronic kidney disease have lipid abnormalities. Here, we investigate whether Niaspan, taken in addition to lipid-lowering drugs referred to as "statins", will decrease LDL cholesterol and increase LDL particle size, increase HDL, reduce proteinuria, and reduce the speed of loss of renal function.

Conditions

• Diabetes Mellitus, Type 2
• Kidney Failure, Chronic
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Extended release niacin	Extended release niacin 1500-2000mg once daily
OTHER	Placebo	Placebo tablets

Timeline

• Start date: 2005-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2005-04-18
• Last updated: 2016-06-22
• Results posted: 2016-05-12

Locations

1 site across 1 country: United States