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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Sevelamer

Criteria

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.