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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chugai Pharma Taiwan
ClinicalTrials.gov Identifier:
NCT01755078
First received: December 19, 2012
Last updated: August 4, 2014
Last verified: December 2012
  Purpose
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 Intervention Phase
Hemodialysis
Hyperphosphatemia
Cardiovascular Events
Drug: Sevelamer HCl
Drug: Calcium-based phosphate binder
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Chugai Pharma Taiwan:

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

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

Enrollment: 166
Study Start Date: June 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 19, 2012
Last Updated: August 4, 2014

Keywords provided by Chugai Pharma Taiwan:
Phosphate binder

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

ClinicalTrials.gov processed this record on May 22, 2017