Cardiovascular Events, Hemodialysis, Hyperphosphatemia
Conditions
Keywords
Phosphate binder
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.
Interventions
DRUGSevelamer HCl
Non-metal phosphate binder
Sponsors
Chugai Pharma Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite end-point of Ca, P, Ca*P within K/DOQI recommendation | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline, lipid profile | 12 months |
| Change from baseline, CRP | 12 months |
| Change from baseline, iPTH (stragified) | 12 months |
| Change from baseline, Ca, P, Ca*P | 12 months |
| CV-related event rate (OPD admission and hospitalization) | 12 months |
| Comparison of medical-related expenses between group | 12 months |
| Change from baseline, homocysteine, folate and Vit B12 | 12 months |
Outcome results
None listed