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

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:
  • Niaspan

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.

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

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

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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