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Sponsored by: |
University of Miami |
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Information provided by: | University of Miami |
ClinicalTrials.gov Identifier: | NCT00108485 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ronald Goldberg, MD | 305-243-6145 | RGoldber@med.miami.edu |
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 |
Principal Investigator: | Ronald Goldberg, MD | University of Miami, Miami, FL |
Study ID Numbers: | PR200408110129 |
Study First Received: | April 15, 2005 |
Last Updated: | November 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00108485 |
Health Authority: | United States: Institutional Review Board |
Diabetes Mellitus, Type 2 Kidney Failure, Chronic Hyperlipidemia Randomized Controlled Trials |
Renal Insufficiency Diabetic Nephropathies Hyperlipidemias Metabolic Diseases Kidney Failure, Chronic Diabetes Mellitus Endocrine System Diseases Nicotinic Acids Urologic Diseases Renal Insufficiency, Chronic |
Diabetes Mellitus, Type 2 Endocrinopathy Kidney Diseases Metabolic disorder Glucose Metabolism Disorders Niacin Diabetes Complications Dyslipidemias Lipid Metabolism Disorders Kidney Failure |