Diabetes is the leading cause of end-stage renal disease (ESRD) in the United States. The
overall rate of ESRD secondary to diabetes has risen 68% since 1992. Medications that block
the renin angiotensin system have been shown to decrease the progression of diabetic
nephropathy. The use of an angiotensin receptor blocker (ARB) has been shown to decrease the
risk of progression of kidney disease in two studies of individuals with Type 2 diabetes and
proteinuria. Despite the use of an ARB, the incidence of renal failure remained high in the
treated group in both studies. The combination of an angiotensin converting enzyme inhibitor
(ACEI) and ARB can lead to more complete blockade of the renin angiotensin system. In
diabetic kidney disease, combination therapy has been shown to decrease proteinuria in
short-term studies. Although there are encouraging results for improvement in proteinuria
there are no data on progression of kidney disease for the use of combination of ACEI and ARB
therapy in patients with diabetes. In addition, there could be an increased risk of serious
hyperkalemia in individuals with diabetes who receive combination ACEI and ARB. The
investigators therefore propose a randomized double blind multi-center clinical trial to
assess the effect of combination of ACEI and ARB in patients with diabetes and proteinuria on
progression of kidney disease.
Phase:
Phase 3
Details
Lead Sponsor:
US Department of Veterans Affairs VA Office of Research and Development