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

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ClinicalTrials.gov Identifier: NCT00108485

Recruitment Status : Terminated (Unable to recruit sufficient study subjects)

First Posted : April 18, 2005

Results First Posted : May 12, 2016

Last Update Posted : June 22, 2016

Sponsor:

Information provided by (Responsible Party):

Ronald Goldberg, University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2 Kidney Failure, Chronic Hyperlipidemia	Drug: Extended release niacin Other: Placebo	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	9 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Randomized, Double-blind, Placebo-controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment
Study Start Date :	April 2005
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholesterol Medicines Diabetic Kidney Problems

Drug Information available for: Niacin Niacinamide

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Extended release niacin Extended release niacin 1500-2000 mg daily versus placebo comparator	Drug: Extended release niacin Extended release niacin 1500-2000mg once daily Other Name: Niaspan
Placebo Comparator: Placebo Placebo tablets	Other: Placebo Placebo tablets

Outcome Measures

Primary Outcome Measures :

Change in Proteinuria [ Time Frame: Baseline, 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108485

Locations

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United States, Florida
Univesity of Miami/Diabetes Research Institute
Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

Investigators

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

More Information

Publications:

Grundy SM, Vega GL, McGovern ME, Tulloch BR, Kendall DM, Fitz-Patrick D, Ganda OP, Rosenson RS, Buse JB, Robertson DD, Sheehan JP; Diabetes Multicenter Research Group. Efficacy, safety, and tolerability of once-daily niacin for the treatment of dyslipidemia associated with type 2 diabetes: results of the assessment of diabetes control and evaluation of the efficacy of niaspan trial. Arch Intern Med. 2002 Jul 22;162(14):1568-76.

Wolfe ML, Vartanian SF, Ross JL, Bansavich LL, Mohler ER 3rd, Meagher E, Friedrich CA, Rader DJ. Safety and effectiveness of Niaspan when added sequentially to a statin for treatment of dyslipidemia. Am J Cardiol. 2001 Feb 15;87(4):476-9, A7.

Guyton JR, Blazing MA, Hagar J, Kashyap ML, Knopp RH, McKenney JM, Nash DT, Nash SD. Extended-release niacin vs gemfibrozil for the treatment of low levels of high-density lipoprotein cholesterol. Niaspan-Gemfibrozil Study Group. Arch Intern Med. 2000 Apr 24;160(8):1177-84.

Whitney EJ, Krasuski RA, Personius BE, Michalek JE, Maranian AM, Kolasa MW, Monick E, Brown BG, Gotto AM Jr. A randomized trial of a strategy for increasing high-density lipoprotein cholesterol levels: effects on progression of coronary heart disease and clinical events. Ann Intern Med. 2005 Jan 18;142(2):95-104.

Owada A, Suda S, Hata T. Antiproteinuric effect of niceritrol, a nicotinic acid derivative, in chronic renal disease with hyperlipidemia: a randomized trial. Am J Med. 2003 Apr 1;114(5):347-53.

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Responsible Party:	Ronald Goldberg, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier:	NCT00108485
Other Study ID Numbers:	20043224
First Posted:	April 18, 2005 Key Record Dates
Results First Posted:	May 12, 2016
Last Update Posted:	June 22, 2016
Last Verified:	May 2016

Keywords provided by Ronald Goldberg, University of Miami:


Diabetes Mellitus, Type 2 Kidney Failure, Chronic Hyperlipidemia Randomized Controlled Trials

Additional relevant MeSH terms:

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Renal Insufficiency Diabetic Nephropathies Kidney Failure, Chronic Diabetes Mellitus Diabetes Mellitus, Type 2 Hyperlipidemias Hyperlipoproteinemias Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Kidney Diseases Urologic Diseases Dyslipidemias	Lipid Metabolism Disorders Diabetes Complications Renal Insufficiency, Chronic Niacin Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs

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