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

Phase 3

Terminated

• Conditions: Diabetes Mellitus, Type 2; Hyperlipidemia; Kidney Failure, Chronic
• Interventions: Drug: Extended release niacin; Other: Placebo

• Registration Number: NCT00108485
• Lead Sponsor: University of Miami

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 have kidney damage due to diabetes. A secondary goal is to test whether Niaspan® slows down further development of kidney damage.

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, 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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-04-15
• Study First Submitted QC: 2005-04-15
• Study First Posted: 2005-04-18
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2015-09-04
• Results First Submitted QC: 2016-04-07
• Status Verified: 2016-05
• Results First Posted: 2016-05-12
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended release niacin	Extended release niacin	Extended release niacin 1500-2000 mg daily versus placebo comparator
Placebo	Placebo	Placebo tablets

Primary Outcome Measures

Name	Time	Method
Change in Proteinuria	Baseline, 1 year

Trial Locations

Locations (1)

Univesity of Miami/Diabetes Research Institute; 🇺🇸 Miami, Florida, United States