Renoprotection in Early Diabetic Nephropathy in Pima Indians
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
This investigation is a randomized, double-blinded, placebo-controlled clinical trial in
adult diabetic Pima Indians with normal urinary albumin excretion (albumin-to-creatinine
ration less than 30 mg/g) or microalbuminuria (albumin-to-creatinine ration = 30-299 mg/g) to
test the hypothesis that blockade of the renin-angiotensin system with the angiotensin
receptor blocker (ARB) losartan can prevent or further attenuate the development and
progression of early diabetic nephropathy in subjects with type 2 diabetes mellitus who are
receiving standard diabetes care.
One hundred seventy subjects were recruited for the study, all of whom had type 2 diabetes
for at least 5 years, serum creatinine concentrations less than 1.4 mg/dl, and no evidence of
non-diabetic renal diseases. Ninety-two of the subjects had normal urinary albumin excretion
at baseline and other 78 had microalbuminuria. Subjects in each albumin excretion group were
randomized to treatment with either the angiotensin II receptor antagonist, losartan, or
placebo. Measurements of glomerular filtration rate (GFR), renal plasma flow (RPF) and
fractional clearances of albumin and IgG will be made initially, at one month, and at
12-month intervals from baseline thereafter. A kidney biopsy was performed after six years in
111 subjects. Morphometric analysis of renal biopsies was used to determine differences in
glomerular structure between treatment groups.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)