Design of Combination Angiotensin Receptor Blocker and Angiotensin-Converting Enzyme Inhibitor for Treatment of Diabetic Nephropathy (VA NEPHRON-D)

Both angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) can slow the progression of diabetic nephropathy. Even with ACEI or ARB treatment, the proportion of patients who progress to end-stage renal disease (ESRD) remains high. Interventions that achieve more co...

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Veröffentlicht in:Clinical journal of the American Society of Nephrology 2009-02, Vol.4 (2), p.361-368
Hauptverfasser: Fried, Linda F, Duckworth, William, Zhang, Jane Hongyuan, O'Connor, Theresa, Brophy, Mary, Emanuele, Nicholas, Huang, Grant D, McCullough, Peter A, Palevsky, Paul M, Seliger, Stephen, Warren, Stuart R, Peduzzi, Peter
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container_end_page 368
container_issue 2
container_start_page 361
container_title Clinical journal of the American Society of Nephrology
container_volume 4
creator Fried, Linda F
Duckworth, William
Zhang, Jane Hongyuan
O'Connor, Theresa
Brophy, Mary
Emanuele, Nicholas
Huang, Grant D
McCullough, Peter A
Palevsky, Paul M
Seliger, Stephen
Warren, Stuart R
Peduzzi, Peter
description Both angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) can slow the progression of diabetic nephropathy. Even with ACEI or ARB treatment, the proportion of patients who progress to end-stage renal disease (ESRD) remains high. Interventions that achieve more complete blockade of the renin-angiotensin system, such as combination ACEI and ARB, might be beneficial. This approach may decrease progression of nondiabetic kidney disease. In diabetic nephropathy, combination therapy decreases proteinuria, but its effect in slowing progression is unknown. In addition, the potential for hyperkalemia may limit the utility of combined therapy in this population. VA NEPHRON-D is a randomized, double-blind, multicenter clinical trial to assess the effect of combination losartan and lisinopril, compared with losartan alone, on the progression of kidney disease in 1850 patients with diabetes and overt proteinuria. The primary endpoints are time to (1) reduction in estimated GFR (eGFR) of > 50% (if baseline < 60 ml/min/1.73 m(2)); (2) reduction in eGFR of 30 ml/min/1.73 m(2) (if baseline > or = 60 ml/min/1.73 m(2)); (3) progression to ESRD (need for dialysis, renal transplant, or eGFR < 15 ml/min/1.73 m(2)); or (4) death. The secondary endpoint is time to change in eGFR or ESRD. Tertiary endpoints are cardiovascular events, slope of change in eGFR, and change in albuminuria at 1 yr. Specific safety endpoints are serious hyperkalemia (potassium > 6 mEq/L, requiring admission, emergency room visit, or dialysis), all-cause mortality, and other serious adverse events. This paper discusses the design and key methodological issues that arose during the planning of the study.
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Even with ACEI or ARB treatment, the proportion of patients who progress to end-stage renal disease (ESRD) remains high. Interventions that achieve more complete blockade of the renin-angiotensin system, such as combination ACEI and ARB, might be beneficial. This approach may decrease progression of nondiabetic kidney disease. In diabetic nephropathy, combination therapy decreases proteinuria, but its effect in slowing progression is unknown. In addition, the potential for hyperkalemia may limit the utility of combined therapy in this population. VA NEPHRON-D is a randomized, double-blind, multicenter clinical trial to assess the effect of combination losartan and lisinopril, compared with losartan alone, on the progression of kidney disease in 1850 patients with diabetes and overt proteinuria. The primary endpoints are time to (1) reduction in estimated GFR (eGFR) of &gt; 50% (if baseline &lt; 60 ml/min/1.73 m(2)); (2) reduction in eGFR of 30 ml/min/1.73 m(2) (if baseline &gt; or = 60 ml/min/1.73 m(2)); (3) progression to ESRD (need for dialysis, renal transplant, or eGFR &lt; 15 ml/min/1.73 m(2)); or (4) death. The secondary endpoint is time to change in eGFR or ESRD. Tertiary endpoints are cardiovascular events, slope of change in eGFR, and change in albuminuria at 1 yr. Specific safety endpoints are serious hyperkalemia (potassium &gt; 6 mEq/L, requiring admission, emergency room visit, or dialysis), all-cause mortality, and other serious adverse events. 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Even with ACEI or ARB treatment, the proportion of patients who progress to end-stage renal disease (ESRD) remains high. Interventions that achieve more complete blockade of the renin-angiotensin system, such as combination ACEI and ARB, might be beneficial. This approach may decrease progression of nondiabetic kidney disease. In diabetic nephropathy, combination therapy decreases proteinuria, but its effect in slowing progression is unknown. In addition, the potential for hyperkalemia may limit the utility of combined therapy in this population. VA NEPHRON-D is a randomized, double-blind, multicenter clinical trial to assess the effect of combination losartan and lisinopril, compared with losartan alone, on the progression of kidney disease in 1850 patients with diabetes and overt proteinuria. The primary endpoints are time to (1) reduction in estimated GFR (eGFR) of &gt; 50% (if baseline &lt; 60 ml/min/1.73 m(2)); (2) reduction in eGFR of 30 ml/min/1.73 m(2) (if baseline &gt; or = 60 ml/min/1.73 m(2)); (3) progression to ESRD (need for dialysis, renal transplant, or eGFR &lt; 15 ml/min/1.73 m(2)); or (4) death. The secondary endpoint is time to change in eGFR or ESRD. Tertiary endpoints are cardiovascular events, slope of change in eGFR, and change in albuminuria at 1 yr. Specific safety endpoints are serious hyperkalemia (potassium &gt; 6 mEq/L, requiring admission, emergency room visit, or dialysis), all-cause mortality, and other serious adverse events. 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control</subject><subject>Kidney Transplantation</subject><subject>Lisinopril - adverse effects</subject><subject>Lisinopril - therapeutic use</subject><subject>Losartan - adverse effects</subject><subject>Losartan - therapeutic use</subject><subject>Prospective Studies</subject><subject>Proteinuria - drug therapy</subject><subject>Proteinuria - etiology</subject><subject>Proteinuria - mortality</subject><subject>Proteinuria - physiopathology</subject><subject>Renal Dialysis</subject><subject>Research Design</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>United States</subject><subject>United States Department of Veterans Affairs</subject><issn>1555-9041</issn><issn>1555-905X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkU1v1DAQhq0KRD_gxhn5hEBqWn_m44K0ZLe0qNqiqkXcLMfrJC6JHdluq-Vv8Ifr1ZbSHqyxPM-845kXgPcYHRGC-XH9fXmEKOWoQOUO2MOc86xC_NerpzvDu2A_hBuEGKOEvwG7uMK4xATtgb9zHUxnoWth7cbGWBmNs3BmO-OitsFYeKmVnqLz8Ovg1G_tobSr50BWO3unfTS2gwv7Zz1qeGZ705hNTZvOldcyjtrGTZe5kY2ORsGlnnrvJhn7Nfz0cwaXix-nlxfLbP75LXjdyiHod4_xAFyfLK7q0-z84ttZPTvPFCuqmNG2zBnHVRo8l5qXjUz7aBgqU0RM56tqMz-tGoUbhBUpVXrFheJlW7AVJfQAfNnqTrfNqFcq_dDLQUzejNKvhZNGvMxY04vO3QmS04KXLAkcbgWUdyF43T7VYiQ25ohkjvhnTsI_PO_3H350IwEft0Bvuv7eeC3CKIch4USoGxksE0TQHNMHpjeZQg</recordid><startdate>20090201</startdate><enddate>20090201</enddate><creator>Fried, Linda F</creator><creator>Duckworth, William</creator><creator>Zhang, Jane Hongyuan</creator><creator>O'Connor, Theresa</creator><creator>Brophy, Mary</creator><creator>Emanuele, Nicholas</creator><creator>Huang, Grant D</creator><creator>McCullough, Peter A</creator><creator>Palevsky, Paul M</creator><creator>Seliger, Stephen</creator><creator>Warren, Stuart R</creator><creator>Peduzzi, Peter</creator><general>American Society of Nephrology</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20090201</creationdate><title>Design of Combination Angiotensin Receptor Blocker and Angiotensin-Converting Enzyme Inhibitor for Treatment of Diabetic Nephropathy (VA NEPHRON-D)</title><author>Fried, Linda F ; Duckworth, William ; Zhang, Jane Hongyuan ; O'Connor, Theresa ; Brophy, Mary ; Emanuele, Nicholas ; Huang, Grant D ; McCullough, Peter A ; Palevsky, Paul M ; Seliger, Stephen ; Warren, Stuart R ; Peduzzi, Peter</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c479t-3f8645190706ae58ba221b408a2204e6d9155539bc1b01c28c04e17c58f74d323</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Angiotensin II Type 1 Receptor Blockers - adverse effects</topic><topic>Angiotensin II Type 1 Receptor Blockers - therapeutic use</topic><topic>Angiotensin-Converting Enzyme Inhibitors - adverse effects</topic><topic>Angiotensin-Converting Enzyme Inhibitors - therapeutic use</topic><topic>Diabetes and the Kidney</topic><topic>Diabetes Mellitus, Type 2 - complications</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - mortality</topic><topic>Diabetes Mellitus, Type 2 - physiopathology</topic><topic>Diabetic Nephropathies - drug therapy</topic><topic>Diabetic Nephropathies - etiology</topic><topic>Diabetic Nephropathies - mortality</topic><topic>Diabetic Nephropathies - physiopathology</topic><topic>Disease Progression</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Glomerular Filtration Rate - drug effects</topic><topic>Humans</topic><topic>Hyperkalemia - chemically induced</topic><topic>Kidney Failure, Chronic - etiology</topic><topic>Kidney Failure, Chronic - mortality</topic><topic>Kidney Failure, Chronic - physiopathology</topic><topic>Kidney Failure, Chronic - prevention &amp; 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subjects Angiotensin II Type 1 Receptor Blockers - adverse effects
Angiotensin II Type 1 Receptor Blockers - therapeutic use
Angiotensin-Converting Enzyme Inhibitors - adverse effects
Angiotensin-Converting Enzyme Inhibitors - therapeutic use
Diabetes and the Kidney
Diabetes Mellitus, Type 2 - complications
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - mortality
Diabetes Mellitus, Type 2 - physiopathology
Diabetic Nephropathies - drug therapy
Diabetic Nephropathies - etiology
Diabetic Nephropathies - mortality
Diabetic Nephropathies - physiopathology
Disease Progression
Double-Blind Method
Drug Therapy, Combination
Glomerular Filtration Rate - drug effects
Humans
Hyperkalemia - chemically induced
Kidney Failure, Chronic - etiology
Kidney Failure, Chronic - mortality
Kidney Failure, Chronic - physiopathology
Kidney Failure, Chronic - prevention & control
Kidney Transplantation
Lisinopril - adverse effects
Lisinopril - therapeutic use
Losartan - adverse effects
Losartan - therapeutic use
Prospective Studies
Proteinuria - drug therapy
Proteinuria - etiology
Proteinuria - mortality
Proteinuria - physiopathology
Renal Dialysis
Research Design
Time Factors
Treatment Outcome
United States
United States Department of Veterans Affairs
title Design of Combination Angiotensin Receptor Blocker and Angiotensin-Converting Enzyme Inhibitor for Treatment of Diabetic Nephropathy (VA NEPHRON-D)
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