Back to resultsLong Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Primary Purpose
Hemodialysis, Hyperphosphatemia, Cardiovascular Events
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sevelamer HCl
Calcium-based phosphate binder
Sponsored by
About this trial
This is an interventional treatment trial for Hemodialysis focused on measuring Phosphate binder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sevelamer HCl
Calcium-based binder
Arm Description
Sevelamer HCl regular treatment 1-3 tablets TID
Calcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID
Outcomes
Primary Outcome Measures
Composite end-point of Ca, P, Ca*P within K/DOQI recommendation
Secondary Outcome Measures
Change from baseline, Ca, P, Ca*P
Change from baseline, lipid profile
Change from baseline, CRP
Change from baseline, iPTH (stragified)
Change from baseline, homocysteine, folate and Vit B12
CV-related event rate (OPD admission and hospitalization)
Comparison of medical-related expenses between group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01755078
Brief Title
Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Official Title
Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chugai Pharma Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, Hyperphosphatemia, Cardiovascular Events
Keywords
Phosphate binder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevelamer HCl
Arm Type
Experimental
Arm Description
Sevelamer HCl regular treatment 1-3 tablets TID
Arm Title
Calcium-based binder
Arm Type
Active Comparator
Arm Description
Calcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID
Intervention Type
Drug
Intervention Name(s)
Sevelamer HCl
Other Intervention Name(s)
Renagel Tablets
Intervention Description
Non-metal phosphate binder
Intervention Type
Drug
Intervention Name(s)
Calcium-based phosphate binder
Other Intervention Name(s)
Calcium carbonate, Calcium acetate
Primary Outcome Measure Information:
Title
Composite end-point of Ca, P, Ca*P within K/DOQI recommendation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline, Ca, P, Ca*P
Time Frame
12 months
Title
Change from baseline, lipid profile
Time Frame
12 months
Title
Change from baseline, CRP
Time Frame
12 months
Title
Change from baseline, iPTH (stragified)
Time Frame
12 months
Title
Change from baseline, homocysteine, folate and Vit B12
Time Frame
12 months
Title
CV-related event rate (OPD admission and hospitalization)
Time Frame
12 months
Title
Comparison of medical-related expenses between group
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiu-Ching Huang, Professor
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
27007989
Citation
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.
Results Reference
derived
Learn more about this trial
Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
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