Sulodexide, a mixture of naturally occurring glycosaminoglycan polysaccharide components, has been
reported to reduce albuminuria in patients with diabetes, but it is unknown whether it is renoprotective.
This study reports the results from the randomized, double-blind, placebo-controlled, sulodexide
macroalbuminuria (Sun-MACRO) trial, which evaluated the renoprotective effects of sulodexide in patients
with type 2 diabetes, renal impairment, and significant proteinuria (.900 mg/d) already receiving maximal
therapy with angiotensin II receptor blockers. The primary end point was a composite of a doubling of baseline
serum creatinine, development of ESRD, or serum creatinine 6.0 mg/dl. We planned to enroll 2240
patients over approximately 24 months but terminated the study after enrolling 1248 patients. After 1029
person-years of follow-up, we did not detect any significant differences between sulodexide and placebo; the
primary composite end point occurred in 26 and 30 patients in the sulodexide and placebo groups, respectively.
Side effect profiles were similar for both groups. In conclusion, these data do not suggest a renoprotective
benefit of sulodexide in patients with type 2 diabetes, renal impairment, and macroalbuminuria.