Niaspan in Diabetic Nephropathy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by University of Miami.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Miami
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00108485
First received: April 15, 2005
Last updated: November 8, 2006
Last verified: November 2006
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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: Niaspan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 HDL (high-density lipoprotein) concentration
- Change in proteinuria
Secondary Outcome Measures:
- Change in LDL (low-density lipoprotein) concentration
- Change in LDL particle size
- Change in estimated GFR (glomerular filtration rate)
- Incidence of adverse events
| Estimated Enrollment: | 48 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | April 2007 |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108485
Contacts
| Contact: Ronald Goldberg, MD | 305-243-6145 | RGoldber@med.miami.edu |
Locations
| United States, Florida | |
| Jackson Memorial Hospital | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Oliver Lenz, MD 305-243-3583 OLenz@med.miami.edu | |
| Contact: Ronald Goldberg, MD 305-243-6145 RGoldber@med.miami.edu | |
| Sub-Investigator: Oliver Lenz, MD | |
| Diabetes Research Institute | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Ronald Goldberg, MD 305-243-6145 RGoldber@med.miami.edu | |
| Principal Investigator: Ronald Goldberg, MD | |
Sponsors and Collaborators
University of Miami
Investigators
| Principal Investigator: | Ronald Goldberg, MD | University of Miami, Miami, FL |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00108485 History of Changes |
| Other Study ID Numbers: | PR200408110129 |
| Study First Received: | April 15, 2005 |
| Last Updated: | November 8, 2006 |
| 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 Diseases Kidney Failure, Chronic Renal Insufficiency Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases Diabetes Complications Dyslipidemias Lipid Metabolism Disorders Renal Insufficiency, Chronic |
Niacin Nicotinic Acids Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013