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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevelamer HCl | Experimental | Sevelamer HCl regular treatment 1-3 tablets TID |
|
| Calcium-based binder | Active Comparator | Calcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevelamer HCl | Drug | Non-metal phosphate binder |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite end-point of Ca, P, Ca*P within K/DOQI recommendation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline, Ca, P, Ca*P | 12 months | |
| Change from baseline, lipid profile | 12 months | |
| Change from baseline, CRP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chiu-Ching Huang, Professor | China Medical University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. | |
| 27007989 | Derived | Lin HH, Liou HH, Wu MS, Huang CC. Factors associated with serum fetuin-A concentrations after long-term use of different phosphate binders in hemodialysis patients. BMC Nephrol. 2016 Mar 23;17:33. doi: 10.1186/s12882-016-0245-3. |
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| Calcium-based phosphate binder | Drug |
|
|
| 12 months |
| Change from baseline, iPTH (stragified) | 12 months |
| Change from baseline, homocysteine, folate and Vit B12 | 12 months |
| CV-related event rate (OPD admission and hospitalization) | 12 months |
| Comparison of medical-related expenses between group | 12 months |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| D002119 | Calcium Carbonate |
| C120662 | calcium acetate |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
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