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

Condition(s) targeted: Diabetes Mellitus, Type 2; Kidney Failure, Chronic; Hyperlipidemia

Intervention: Extended release niacin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: University of Miami

Official(s) and/or principal investigator(s):
Ronald Goldberg, MD, Principal Investigator, Affiliation: University of Miami, Miami, FL

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.

Official title: Randomized, Double-blind, Placebo-controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in proteinuria

Secondary outcome:

Change in LDL (low-density lipoprotein) concentration

Change in LDL particle size

Change in estimated GFR (glomerular filtration rate)

Incidence of adverse events

Change in HDL-C

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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

Related 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.

Starting date: April 2005
Last updated: July 29, 2014