| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Diabetes and the Kidney |
* Veterans Affairs (VA) Pittsburgh Healthcare System and Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylviania; Carl T. Hayden VA Medical Center, School of Life Sciences, Arizona State University, and Department of Medicine, University of Arizona, Phoenix, Arizona; West Haven VA Cooperative Studies Program Coordinating Center, West Haven, Connecticut; VA Boston Healthcare System and Department of Medicine, Boston University School of Medicine, Boston, Massachusetts; ¶ Hines VA and Department of Medicine, Loyola University Medical Center, Hines Illinois; || Cooperative Studies Program Headquarters, VA Office Research and Development, Washington, District of Columbia; ** Department of Medicine, William Beaumont Hospital, Royal Oak, Michigan; VA Maryland Medical Center and Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, VA Cooperative Studies Program Research Pharmacy and University of New Mexico College of Pharmacy, Albuquerque, New Mexico
Correspondence: Dr. Linda F. Fried, MD, MPH, VA Pittsburgh Healthcare System, University Drive Division, Mailstop 111F-U, Pittsburgh, PA 15240. Phone: 412-360-6181; Fax: 412-360-6908; E-mail: Linda.Fried{at}va.gov
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 m2); (2) reduction in eGFR of 30 ml/min/1.73 m2 (if baseline 
60 ml/min/1.73 m2); (3) progression to ESRD (need for dialysis, renal transplant, or eGFR < 15 ml/min/1.73 m2); 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.
This article has been cited by other articles:
|
|
 |
|
  D. Dobre, H. J. Lambers Heerspink, and D. de Zeeuw Reducing cardiovascular risk: protecting the kidney Eur. Heart J. Suppl., December 1, 2009; 11(suppl_F): F39 - F46. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. Frimodt-Moller, A. Hoj Nielsen, S. Strandgaard, and A.-L. Kamper Feasibility of combined treatment with enalapril and candesartan in advanced chronic kidney disease Nephrol. Dial. Transplant., November 9, 2009; (2009) gfp547v1. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Haynes, P. Mason, K. Rahimi, and M. J Landray Dual blockade of the renin-angiotensin system: are two better than one? Nephrol. Dial. Transplant., September 17, 2009; (2009) gfp458v1. [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
