Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients

Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients

The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.

Inclusion Criteria:

• Males or females aged between 18-70 years old
• Subject with hyperphosphatemia (5.5 - 8.5 mg/dL) at both WK(-2) and WK0
• On stable TIW hemodialysis for 3 months or longer

Exclusion Criteria:

• Patients with hypercalcemia (corrected serum calcium > 10.5 mg/dL)
• Any of the following abnormalities: ALT or AST > 3X ULN; iPTH > 1000 or < 150 pg/mL
• History of dysphagia or swallowing disorders
• History of GI motility disorder or GI bleeding within 3 months prior to entry