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

University of Miami

Status and phase

Terminated

Phase 3

Conditions

Hyperlipidemia

Diabetes Mellitus, Type 2

Kidney Failure, Chronic

Treatments

Drug: Extended release niacin

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00108485

20043224

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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