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

NCT00108485 | Terminated Phase 3 Results

• 1 other identifier: 20043224
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Kidney Failure, Chronic; Hyperlipidemia

Keywords

Diabetes Mellitus, Type 2; Kidney Failure, Chronic; Hyperlipidemia; Randomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

• Change in Proteinuria

  Baseline, 1 year

Study Arms (2)

Extended release niacin

ACTIVE COMPARATOR

Extended release niacin 1500-2000 mg daily versus placebo comparator

Drug: Extended release niacin

Placebo

PLACEBO COMPARATOR

Placebo tablets

Other: Placebo

Interventions

Extended release niacin DRUG

Extended release niacin 1500-2000mg once daily

Also known as: Niaspan

Extended release niacin

Placebo OTHER

Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Univesity of Miami/Diabetes Research Institute

Miami, Florida, 33136, United States

Location

Related Publications (5)

• 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.

  PMID: 12123399 BACKGROUND

• 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.

  PMID: 11179541 BACKGROUND

• 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.

  PMID: 10789612 BACKGROUND

• 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.

  PMID: 15657157 BACKGROUND

• 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.

  PMID: 12714122 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Kidney Failure, Chronic; Hyperlipidemias

Interventions

Niacin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Early termination of study lead to small number of subjects analyzed.

Results Point of Contact

• Title: Dr. Ronald Goldberg
• Organization: Diabetes Research Institute

RGoldber@med.miami.edu

305-243-6574

Study Officials

• Ronald Goldberg, MD

  University of Miami, Miami, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 15, 2005
• First Posted: April 18, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 22, 2016
• Results First Posted: May 12, 2016

Record last verified: 2016-05

Locations

US (1)