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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Extended release niacin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extended release niacin<br>Extended release niacin 1500-2000 mg daily versus placebo comparator | Drug: Extended release niacin<br>* Extended release niacin 1500-2000mg once daily<br>* Other names: Niaspan;|
| Placebo Comparator: Placebo<br>Placebo tablets | Other: Placebo<br>* Placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Proteinuria |  | Baseline, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Hyperlipidemia, Randomized Controlled Trials