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:
Information provided by (Responsible Party):
Ronald Goldberg, University of Miami
ClinicalTrials.gov Identifier:
NCT00108485
First received: April 15, 2005
Last updated: July 29, 2014
Last verified: July 2014
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in LDL (low-density lipoprotein) concentration [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in LDL particle size [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in estimated GFR (glomerular filtration rate) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Change in HDL-C [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 17
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 15, 2005
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014