- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00108485
Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy
May 17, 2016 updated by: Ronald Goldberg, University of Miami
Randomized, Double-blind, Placebo-controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment
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.
Study Overview
Status
Terminated
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Univesity of Miami/Diabetes Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo tablets
|
Placebo tablets
|
Active Comparator: Extended release niacin
Extended release niacin 1500-2000 mg daily versus placebo comparator
|
Extended release niacin 1500-2000mg once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Proteinuria
Time Frame: Baseline, 1 year
|
Baseline, 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ronald Goldberg, MD, University of Miami, Miami, FL
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1001/archinte.162.14.1568.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
April 15, 2005
First Submitted That Met QC Criteria
April 15, 2005
First Posted (Estimate)
April 18, 2005
Study Record Updates
Last Update Posted (Estimate)
June 22, 2016
Last Update Submitted That Met QC Criteria
May 17, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Kidney Diseases
- Urologic Diseases
- Endocrine System Diseases
- Diabetes Complications
- Renal Insufficiency, Chronic
- Lipid Metabolism Disorders
- Dyslipidemias
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Diabetic Nephropathies
- Kidney Failure, Chronic
- Renal Insufficiency
- Hyperlipidemias
- Hyperlipoproteinemias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Antimetabolites
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Vitamin B Complex
- Niacin
Other Study ID Numbers
- 20043224
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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