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Miami, Florida 33136


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00108485


Primary Contact:

Principal Investigator
Ronald Goldberg, MD
University of Miami, Miami, FL


Backup Contact:

N/A


Location Contact:

Miami, Florida 33136
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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