Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
NCT ID: NCT01755078
Last Updated: 2014-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
166 participants
INTERVENTIONAL
2007-06-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sevelamer HCl
Sevelamer HCl regular treatment 1-3 tablets TID
Sevelamer HCl
Non-metal phosphate binder
Calcium-based binder
Calcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID
Calcium-based phosphate binder
Interventions
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Sevelamer HCl
Non-metal phosphate binder
Calcium-based phosphate binder
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Chugai Pharma Taiwan
INDUSTRY
Responsible Party
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Principal Investigators
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Chiu-Ching Huang, Professor
Role: PRINCIPAL_INVESTIGATOR
China Medical University Hospital
References
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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.
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.
Other Identifiers
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CPT-REN-002
Identifier Type: -
Identifier Source: org_study_id
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