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

This study has been terminated.
(Unable to recruit sufficient study subjects)
Information provided by (Responsible Party):
Ronald Goldberg, University of Miami Identifier:
First received: April 15, 2005
Last updated: May 17, 2016
Last verified: May 2016
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 Intervention Phase
Diabetes Mellitus, Type 2
Kidney Failure, Chronic
Drug: Extended release niacin
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment

Resource links provided by NLM:

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Change in Proteinuria [ Time Frame: Baseline, 1 year ]

Enrollment: 9
Study Start Date: April 2005
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Extended release niacin
Extended release niacin 1500-2000 mg daily versus placebo comparator
Drug: Extended release niacin
Extended release niacin 1500-2000mg once daily
Other Name: Niaspan
Placebo Comparator: Placebo
Placebo tablets
Other: Placebo
Placebo tablets

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00108485

United States, Florida
Univesity of Miami/Diabetes Research Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Principal Investigator: Ronald Goldberg, MD University of Miami, Miami, FL
  More Information

Responsible Party: Ronald Goldberg, Professor of Medicine, University of Miami Identifier: NCT00108485     History of Changes
Other Study ID Numbers: 20043224
Study First Received: April 15, 2005
Results First Received: September 4, 2015
Last Updated: May 17, 2016

Keywords provided by University of Miami:
Diabetes Mellitus, Type 2
Kidney Failure, Chronic
Randomized Controlled Trials

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Diabetic Nephropathies
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Kidney Diseases
Urologic Diseases
Diabetes Complications
Renal Insufficiency, Chronic
Nicotinic Acids
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on April 26, 2017