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: December 20, 2012
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline, Ca, P, Ca*P [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline, lipid profile [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline, CRP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline, iPTH (stragified) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline, homocysteine, folate and Vit B12 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • CV-related event rate (OPD admission and hospitalization) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Comparison of medical-related expenses between group [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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 Drug: Sevelamer HCl
Non-metal phosphate binder
Other Name: Renagel Tablets
Active Comparator: Calcium-based binder Drug: Calcium-based phosphate binder
Other Names:
  • Calcium carbonate
  • Calcium acetate

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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

No publications provided

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: December 20, 2012
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

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
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Chelating Agents

ClinicalTrials.gov processed this record on April 21, 2014