Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
1 other identifier
interventional
166
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 19, 2012
CompletedFirst Posted
Study publicly available on registry
December 21, 2012
CompletedAugust 5, 2014
December 1, 2012
2 years
December 19, 2012
August 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite end-point of Ca, P, Ca*P within K/DOQI recommendation
12 months
Secondary Outcomes (7)
Change from baseline, Ca, P, Ca*P
12 months
Change from baseline, lipid profile
12 months
Change from baseline, CRP
12 months
Change from baseline, iPTH (stragified)
12 months
Change from baseline, homocysteine, folate and Vit B12
12 months
- +2 more secondary outcomes
Study Arms (2)
Sevelamer HCl
EXPERIMENTALSevelamer HCl regular treatment 1-3 tablets TID
Calcium-based binder
ACTIVE COMPARATORCalcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 40576086DERIVEDLin 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.
PMID: 27007989DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chiu-Ching Huang, Professor
China Medical University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2012
First Posted
December 21, 2012
Study Start
June 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
August 5, 2014
Record last verified: 2012-12