Niaspan in Diabetic Nephropathy - Full Text View

Sponsored by:	University of Miami
Information provided by:	University of Miami
ClinicalTrials.gov Identifier:	NCT00108485

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Kidney Failure, Chronic Hyperlipidemia	Drug: Niaspan	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Double-Blind, Placebo-Controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetic Kidney Problems Kidney Failure

Drug Information available for: Niacin Niacin hydrochloride

U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:

Change in HDL (high-density lipoprotein) concentration
Change in proteinuria

Secondary Outcome Measures:

Change in LDL (low-density lipoprotein) concentration
Change in LDL particle size
Change in estimated GFR (glomerular filtration rate)
Incidence of adverse events

Estimated Enrollment:	48
Study Start Date:	April 2005
Estimated Study Completion Date:	April 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108485

Contacts

Contact: Ronald Goldberg, MD

305-243-6145

RGoldber@med.miami.edu

Locations

United States, Florida
Jackson Memorial Hospital	Recruiting
Miami, Florida, United States, 33136
Contact: Oliver Lenz, MD 305-243-3583 OLenz@med.miami.edu
Contact: Ronald Goldberg, MD 305-243-6145 RGoldber@med.miami.edu
Sub-Investigator: Oliver Lenz, MD
Diabetes Research Institute	Recruiting
Miami, Florida, United States, 33136
Contact: Ronald Goldberg, MD 305-243-6145 RGoldber@med.miami.edu
Principal Investigator: Ronald Goldberg, MD

Sponsors and Collaborators

University of Miami

Investigators

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. Summary for patients in: Ann Intern Med. 2005 Jan 18;142(2):I46.

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.

Study ID Numbers:	PR200408110129
Study First Received:	April 15, 2005
Last Updated:	November 8, 2006
ClinicalTrials.gov Identifier:	NCT00108485 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Miami:

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

Study placed in the following topic categories:

Renal Insufficiency
Diabetic Nephropathies
Hyperlipidemias
Metabolic Diseases
Kidney Failure, Chronic
Diabetes Mellitus
Endocrine System Diseases
Nicotinamide
Nicotinic Acids
Urologic Diseases
Renal Insufficiency, Chronic

Diabetes Mellitus, Type 2
Endocrinopathy
Kidney Diseases
Nicotinic Acid
Glucose Metabolism Disorders
Niacin
Metabolic Disorder
Diabetes Complications
Dyslipidemias
Lipid Metabolism Disorders
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Diabetic Nephropathies
Hyperlipidemias
Metabolic Diseases
Diabetes Mellitus
Kidney Failure, Chronic
Endocrine System Diseases
Urologic Diseases

Renal Insufficiency, Chronic
Diabetes Mellitus, Type 2
Kidney Diseases
Glucose Metabolism Disorders
Diabetes Complications
Dyslipidemias
Lipid Metabolism Disorders
Kidney Failure

ClinicalTrials.gov processed this record on September 03, 2009