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

August 4, 2014 updated by: Chugai Pharma Taiwan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevelamer HCl
Sevelamer HCl regular treatment 1-3 tablets TID
Drug: Sevelamer HCl
Non-metal phosphate binder
Other Names:
  • 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 acetate
  • Calcium carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite end-point of Ca, P, Ca*P within K/DOQI recommendation
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharma Taiwan

Investigators

  • Principal Investigator: Chiu-Ching Huang, Professor, China Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPT-REN-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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