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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugai Pharma Taiwan
• Treatments: Calcium; Calcium acetate; Calcium Carbonate; Calcium, Dietary; Sevelamer

Criteria

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