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

Stopped early · Phase 3 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT00108485

Run by

University of Miami

People needed

9

Starts

2005-04-01

Expected to finish

2012-12-01

Last updated by the study team

2016-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Univesity of Miami/Diabetes Research Institute — Miami, Florida, United States

Full record on ClinicalTrials.gov

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