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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Diabetes Mellitus, Type 2 Kidney Failure, Chronic Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Extended release niacin

Extended release niacin 1500-2000 mg daily versus placebo comparator

Group Type ACTIVE_COMPARATOR

Extended release niacin

Intervention Type DRUG

Extended release niacin 1500-2000mg once daily

Placebo

Placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets

Interventions

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Extended release niacin

Extended release niacin 1500-2000mg once daily

Intervention Type DRUG

Placebo

Placebo tablets

Intervention Type OTHER

Other Intervention Names

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Niaspan

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No