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Published on 3 November 2011

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Kidney drug trial stopped after negative results

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Sulodexide is not effective as a treatment for diabetes patients with kidney disease, according to a study published in the Journal of the American Society Nephrology (JASN).

The drug has been used for more than 20 years to treat various heart conditions and previous research indicated that sulodexide reduces excretion of protein in the urine, which is a hallmark of kidney disease.

To test the effects of sulodexide on the kidneys in a large and extensive trial, David Packham and colleagues from the Melbourne Renal Research Group in Australia conducted a randomised, double-blind, placebo-controlled study in patients with diabetes and kidney disease.

The researchers planned to enrol 2,240 patients in the Sun-MACRO trial over a period of two years, but stopped the study early after enrolling 1,248 patients because they did not detect any significant differences between sulodexide and placebo for preventing kidney failure.

Also, the trial did not confirm the potentially beneficial effect of sulodexide in reducing urinary protein excretion that was previously reported in smaller studies.

“In view of the negative results of Sun-MICRO trial and the data analysis from this study, it is tempting to conclude that sulodexide has no therapeutic benefit in type 2 diabetic nephropathy,” the authors concluded.

Journal of the American Society Nephrology



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