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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01755078
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : August 5, 2014
Information provided by (Responsible Party):
Chugai Pharma Taiwan

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

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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
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Dialysis

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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01755078

Sponsors and Collaborators
Chugai Pharma Taiwan
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Principal Investigator: Chiu-Ching Huang, Professor China Medical University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Chugai Pharma Taiwan Identifier: NCT01755078    
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:
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Phosphorus Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Calcium Carbonate
Calcium acetate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Chelating Agents
Sequestering Agents