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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00381134 |
Kidney disease affects about one out of three people with diabetes mellitus, a common medical problem. Treatment of kidney disease with medications that lower blood pressure can slow the kidney disease but there is no known cure. This study is designed to test the hypothesis that certain combination-based blood pressure lowering regimens (of FDA approved medications) are better than single agent-based regimens for lowering blood pressure and further slowing or preventing progression of this incurable disease
Condition | Intervention | Phase |
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Diabetes Kidney Disease Hypertension |
Drug: losartan 100 mg orally once daily Drug: spironolactone 25 mg orally once daily Drug: placebo once orally once daily |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Improving Outcomes in Diabetic Nephropathy |
Estimated Enrollment: | 92 |
Study Start Date: | July 2003 |
Study Completion Date: | December 2006 |
The long-range objective of this project is to prevent progression of diabetic nephropathy, the leading cause of end-stage renal disease (ESRD). In most patients diabetic nephropathy progresses inexorably to ESRD despite inhibition of the renin-angiotensin- aldosterone system with angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type 1 receptor blockers (ARBs). The specific aims of this proposal are to: 1) recruit a multiethnic cohort of 78 young adults (ages 20-40) with type 1 (n=36) or type 2 (n=36) diabetes and overt nephropathy (defined as a urine albumin/creatinine ratio > 300 mg albumin/g creatinine) and randomize in a double blind fashion to a control group consisting of ACEI-based therapy alone (ramipril 40 mg once daily) or one of two experimental groups: a) ACEI + ARB (ramipril 40 mg once daily plus losartan 100 mg once daily) or b) ACEI + mineralocorticoid receptor antagonist (MRA) (ramipril 40 mg once daily plus spironolactone 25 mg once daily); 2) conduct a 12-month prospective study to determine if proteinuria is reduced to a greater extent when either the ARB or MRA is added to ACEi-based therapy. This study is powered to detect a 30% greater reduction in 24-hour urine albumin/creatinine ratio in either experimental group versus control (alpha = 0.05, beta=0.10, repeated measures analysis of variance). Secondary endpoints to be examined include: (a) serum potassium and creatinine to assess safety, (b) TGF-beta, as a surrogate marker for ongoing renal injury, (c) plasma renin activity, angiotensin II and aldosterone levels and (d) plasma lipids and lipoprotein composition; and 3) perform repeated ambulatory blood pressure monitoring (ABPM) to examine the renoprotective effect of the 3 different regimens at comparable 24-hour BP of < 125/75 mmHg. The deliverables include: 1) documentation of the safety of maximal dose combination therapy; 2) the feasibility of utilizing 24-hr ABPM to establish BP independent renoprotective effects of specific antihypertensive therapies; and 3) provide preliminary data for future large-scale studies to test efficacy and safety of combining ACEi with MRA therapy on renal outcomes.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
The University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75230 |
Principal Investigator: | Robert D Toto, MD | The University of Texas Southwestern Medical Center Dallas |
Study ID Numbers: | DK063010-04 |
Study First Received: | September 26, 2006 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00381134 |
Health Authority: | United States: Federal Government |
double-blind placebo-controlled nephropathy |
blood pressure urine albumin to creatinine ratio placebo |
Losartan Diabetic Nephropathies Metabolic Diseases Diabetes Mellitus Vascular Diseases Endocrine System Diseases Spironolactone |
Urologic Diseases Kidney Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Hypertension |
Aldosterone Antagonists Natriuretic Agents Therapeutic Uses Hormone Antagonists Physiological Effects of Drugs |
Diuretics Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |