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Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT01755078
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Hemodialysis Hyperphosphatemia Cardiovascular Events Drug: Sevelamer HCl Drug: Calcium-based phosphate binder Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Study Start Date : June 2007
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Dialysis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Sevelamer HCl
Sevelamer HCl regular treatment 1-3 tablets TID
Drug: Sevelamer HCl
Non-metal phosphate binder
Other Name: Renagel Tablets
Active Comparator: Calcium-based binder
Calcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID
Drug: Calcium-based phosphate binder
Other Names:
  • Calcium carbonate
  • Calcium acetate


Outcome Measures

Primary Outcome Measures :
  1. Composite end-point of Ca, P, Ca*P within K/DOQI recommendation [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change from baseline, Ca, P, Ca*P [ Time Frame: 12 months ]
  2. Change from baseline, lipid profile [ Time Frame: 12 months ]
  3. Change from baseline, CRP [ Time Frame: 12 months ]
  4. Change from baseline, iPTH (stragified) [ Time Frame: 12 months ]
  5. Change from baseline, homocysteine, folate and Vit B12 [ Time Frame: 12 months ]
  6. CV-related event rate (OPD admission and hospitalization) [ Time Frame: 12 months ]
  7. Comparison of medical-related expenses between group [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755078


Sponsors and Collaborators
Chugai Pharma Taiwan
Investigators
Principal Investigator: Chiu-Ching Huang, Professor China Medical University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chugai Pharma Taiwan
ClinicalTrials.gov Identifier: NCT01755078     History of Changes
Other Study ID Numbers: CPT-REN-002
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: December 2012

Keywords provided by Chugai Pharma Taiwan:
Phosphate binder

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Calcium Carbonate
Sevelamer
Calcium acetate
Bone Density Conservation Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Chelating Agents
Sequestering Agents