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Diabetic Kidney Problems |
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Clinical Trial: Niaspan in Diabetic Nephropathy
This study is currently recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 Kidney Failure, Chronic Hyperlipidemia | Drug: Niaspan | Phase II |
MedlinePlus related topics: Diabetes; Kidney Failure; Metabolic Disorders
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
Secondary Outcomes: Change in LDL (low-density lipoprotein) concentration; Change in LDL particle size; Change in estimated GFR (glomerular filtration rate); Incidence of adverse events
Expected Total Enrollment: 48
Study start: April 2005; Expected completion: July 2007
Last follow-up: April 2007; Data entry closure: April 2007
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 above, Genders Eligible for Study: 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 proteinuria 0.3-3.5 g/d
- Diagnosis of hyperlipidemia currently treated with a "statin" drug
Exclusion Criteria:
- Not meeting inclusion criteria
- LDL-C > 130 mg/dL
- 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%)
- Known seropositivity for Hepatitis B, C, or HIV
- Documented history of malignancy
- Stage 2 hypertension
- Age < 18 years
- Pregnant women or nursing mothers
- Inability to give informed consent
- Start or change in "statin" dose < 2 months ago
Location and Contact Information
Florida
Jackson Memorial Hospital, Miami, Florida, 33136, United States; Recruiting
Ronald Goldberg, MD 305-243-6145 RGoldberg@med.miami.edu
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.
Record last reviewed: April 2005
Last Updated: April 18, 2005
Record first received: April 15, 2005
ClinicalTrials.gov Identifier: NCT00108485
Health Authority: United States: Institutional Review Board (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-03
Source: ClinicalTrials.gov
Cache Date: May 4, 2005
Resources
- American Diabetes Association
- ClinicalTrials.gov: Diabetic Nephropathies (National Institutes of Health)
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