Clinical trial NCT00108485: Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy
Official title: Randomized, Double-blind, Placebo-controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Kidney Failure, Chronic
Hyperlipidemia
Keywords: Diabetes Mellitus, Type 2
Kidney Failure, Chronic
Hyperlipidemia
Randomized Controlled Trials
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2005-04-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Proteinuria
timeFrame: Baseline, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Univesity of Miami/Diabetes Research Institute
state: Florida
Study officials:
affiliation: University of Miami, Miami, FL
name: Ronald Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1001/archinte.162.14.1568.
citation: 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. doi: 10.1016/s0002-9149(00)01410-7.
citation: 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. doi: 10.1001/archinte.160.8.1177.
citation: 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. doi: 10.7326/0003-4819-142-2-200501180-00008.
citation: 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. doi: 10.1016/s0002-9343(02)01567-x.