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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00108485
First Posted: April 18, 2005
Last Update Posted: June 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ronald Goldberg, University of Miami
  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 Intervention Phase
Diabetes Mellitus, Type 2 Kidney Failure, Chronic Hyperlipidemia Drug: Extended release niacin Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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 Ronald Goldberg, 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108485


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

Publications:
Responsible Party: Ronald Goldberg, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT00108485     History of Changes
Other Study ID Numbers: 20043224
First Submitted: April 15, 2005
First Posted: April 18, 2005
Results First Submitted: September 4, 2015
Results First Posted: May 12, 2016
Last Update Posted: June 22, 2016
Last Verified: May 2016

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Hyperlipoproteinemias
Renal Insufficiency
Diabetic Nephropathies
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Kidney Diseases
Urologic Diseases
Diabetes Complications
Renal Insufficiency, Chronic
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs