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

Phase 4

Completed

• Conditions: Hyperphosphatemia; Cardiovascular Events; Hemodialysis
• Interventions: Drug: Sevelamer HCl; Drug: Calcium-based phosphate binder

• Registration Number: NCT01755078
• Lead Sponsor: Chugai Pharma Taiwan

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 Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-12
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-21
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevelamer HCl	Sevelamer HCl	Sevelamer HCl regular treatment 1-3 tablets TID
Calcium-based binder	Calcium-based phosphate binder	Calcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID

Primary Outcome Measures

Name	Time	Method
Composite end-point of Ca, P, Ca*P within K/DOQI recommendation	12 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline, CRP	12 months
Change from baseline, lipid profile	12 months
Change from baseline, iPTH (stragified)	12 months
CV-related event rate (OPD admission and hospitalization)	12 months
Change from baseline, homocysteine, folate and Vit B12	12 months
Comparison of medical-related expenses between group	12 months
Change from baseline, Ca, P, Ca*P	12 months