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

Chugai Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Hemodialysis; Cardiovascular Events; Hyperphosphatemia

Treatments: Drug: Calcium-based phosphate binder; Drug: Sevelamer HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01755078

CPT-REN-002

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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166 participants in 2 patient groups

Sevelamer HCl

Experimental group

Description:

Sevelamer HCl regular treatment 1-3 tablets TID

Treatment:

Drug: Sevelamer HCl

Calcium-based binder

Active Comparator group

Description:

Calcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID

Treatment:

Drug: Calcium-based phosphate binder