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

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• Diagnosis of type 2 diabetes

• Diagnosis of chronic kidney disease stage 2 or 3 with an estimated GFR of 30-89 ml/min using the four variable MDRD (Modification of Diet in Renal Disease Study Group) formula

• Presence of microalbuminuria or proteinuria less than 3.5 g/d

• Diagnosis of hyperlipidemia currently treated with a "statin" drug

Exclusion Criteria:

• Not meeting inclusion criteria

• HDL-C > 40 mg/dL for men, > 50 mg/dL for women

• TG (triglycerides) < 150 mg/dL and > 800 mg/dL

• Documented intolerance to Niaspan or Aspirin

• Treatment with other lipid-lowering agents (fibrates, BAS [bile acid sequestrants], or ezetimibe)

• Elevated transaminases (AST or ALT >1.3 x ULN)

• Unstable type 2 diabetes (FBG >200 mg/dL or HbA1c >9.5%)

• Known seropositivity for Hepatitis B, C, or HIV

• Documented history of malignancy

• Age < 18 years

• Pregnant women or nursing mothers

• Inability to give informed consent

• Start or change in "statin" dose < 2 months ago