Niaspan in Diabetic Nephropathy
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Renal Impairment / Chronic Kidney Disease, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | April 2005 |
| End Date: | April 2007 |
| Contact: | Ronald Goldberg, MD |
| Email: | RGoldber@med.miami.edu |
| Phone: | 305-243-6145 |
Randomized, Double-Blind, Placebo-Controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment
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.
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.
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.
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.
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
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