Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis

A 12-week, Open Label, Multicenter, Titration Study, With a 12 Month Extension, to Determine the Optimal Titration Regimen for SBR759, Compared to Sevelamer HCl, in Lowering Serum Phosphate Levels in Asian Patients With Chronic Kidney Disease on Hemodialysis

This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis

Inclusion criteria

• Men or women of at least 18 years old or 20 years old in Japan.
• Stable maintenance of hemodialysis 3 times per week.
• Controlled serum phosphate if under phosphate-binder therapy.
• Serum phosphate level > 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation.

Exclusion criteria

• Peritoneal dialysis or a non-conventional hemodialysis technique .
• Parathyroidectomy or transplant scheduled during the study.
• Uncontrolled hyperparathyroidism
• History of hemochromatosis or ferritin > 800 µg/L.
• Clinically significant GI disorder
• Unstable medical condition other than Chronic Kidney Disease.
• Treated with sevelamer HCl monotherapy or SBR759.
• Treated with oral iron.
• Other protocol-defined inclusion/exclusion criteria may apply.