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

Information source: University of Miami
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Summary

The primary purpose of this study is to test the effectiveness and tolerability of NiaspanŽ 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 NiaspanŽ slows down further development of kidney damage.

Clinical Details

Official title: Randomized, Double-blind, Placebo-controlled Trial of NiaspanŽ 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.

Eligibility

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

Locations and Contacts

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

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

Page last updated: August 23, 2015

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