Yonsei Med J.  2011 Jul;52(4):588-594. 10.3349/ymj.2011.52.4.588.

Anti-Proteinuric Effect of Sulodexide in Immunoglobulin A Nephropathy

Affiliations
  • 1Department of Internal Medicine, Eulji University of Medicine, Daejeon, Korea.
  • 2Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
  • 3Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
  • 4Clinical Research Institute, Seoul National University Hospital, Seoul, Korea.
  • 5Transplantation Research Institute, Seoul National University, Seoul, Korea.
  • 6Department of Internal Medicine, Seoul National University College of Medicine, Transplantation Research Institute, Seoul, Korea. khoh@snu.ac.kr

Abstract

PURPOSE
We conducted a multi-center randomized double-blind study to determine the effects of 6-month therapy with sulodexide on urinary protein excretion in patients with idiopathic Immunoglobulin A (IgA) nephropathy.
MATERIALS AND METHODS
A total of seventy-seven patients participated in the study. They were randomly allocated to one of three groups: sulodexide 75 mg or 150 mg daily or the placebo for 6 months. The primary end point was the achievement, at 6 months, of at least 50% reduction in urine protein/creatinine ratio (UPCR) from the baseline value.
RESULTS
At 6 months, the primary end point was achieved by 12.5% of the patients assigned to the placebo, 4.0% of the patients assigned to sulodexide 75 mg daily and 21.4% of those assigned to 150 mg (p=0.308). Treatment with sulodexide 150 mg daily for 6 months significantly reduced log UPCR from 6.38+/-0.77 at baseline to 5.98+/-0.94 at 6 months (p=0.045), while treatment with sulodexide 75 mg daily and placebo did not.
CONCLUSION
A 6-month treatment with sulodexide did not achieve 50% reduction of urinary protein excretion in IgA nephropathy patients, but showed a tendency to increase the time-dependent anti-proteinuric effect. Therefore, long-term clinical trials on a larger scale are warranted to elucidate the hypothesis that sulodexide affords renal protection in IgA nephropathy patients.

Keyword

IgA nephropathy; sulodexide; proteinuria

MeSH Terms

Adult
Anticoagulants/*therapeutic use
Double-Blind Method
Female
Glomerulonephritis, IGA/complications/*drug therapy
Glycosaminoglycans/*therapeutic use
Humans
Male
Middle Aged
Proteinuria/complications/*drug therapy

Figure

  • Fig. 1 Patient profiles; the number of patients who were screened for the study, underwent randomization, and completed the study. Some patients were excluded for more than one reason.

  • Fig. 2 Changes from baseline in urinary protein-to-creatinine ratio (UPCR) according to study group. The change from the baseline, in the geometric mean, with 95% confidence intervals, is shown for UPCR.


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