Status:
TERMINATED
Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy
Lead Sponsor:
University of Miami
Conditions:
Diabetes Mellitus, Type 2
Kidney Failure, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 hav...
Detailed Description
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, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00108485
Start Date
April 1 2005
End Date
December 1 2012
Last Update
June 22 2016
Active Locations (1)
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1
Univesity of Miami/Diabetes Research Institute
Miami, Florida, United States, 33136