Clinical Trial: Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Brief 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.
Detailed Summary:
Sponsor: Chugai Pharma Taiwan
Current Primary Outcome: Composite end-point of Ca, P, Ca*P within K/DOQI recommendation [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline, Ca, P, Ca*P [ Time Frame: 12 months ]
- Change from baseline, lipid profile [ Time Frame: 12 months ]
- Change from baseline, CRP [ Time Frame: 12 months ]
- Change from baseline, iPTH (stragified) [ Time Frame: 12 months ]
- Change from baseline, homocysteine, folate and Vit B12 [ Time Frame: 12 months ]
- CV-related event rate (OPD admission and hospitalization) [ Time Frame: 12 months ]
- Comparison of medical-related expenses between group [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Chugai Pharma Taiwan
Dates:
Date Received: December 19, 2012
Date Started: June 2007
Date Completion:
Last Updated: August 4, 2014
Last Verified: December 2012
